Medical Device Manufacturer · GB , Gloucester, Gloucesterhsire

Spectrum Medical , Ltd.

15 submissions · 15 cleared · Since 2007
15
Total
15
Cleared
0
Denied

Spectrum Medical , Ltd. — FDA 510(k) Submissions

Spectrum Medical , Ltd. has submitted 15 FDA 510(k) premarket notifications since 2007, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Monitor, Blood-gas, On-line, Cardiopulmonary Bypass, Gas Control Unit, Cardiopulmonary Bypass, Console, Heart-lung Machine, Cardiopulmonary Bypass, Control, Pump Speed, Cardiopulmonary Bypass, Controller, Temperature, Cardiopulmonary Bypass . Use the specialty filter in the sidebar to narrow results.

15 devices
1–15 of 15
Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
K240908 · DTR Heat-exchanger,... · Cardiovascular
Jul 2025 462d
Quantum Heater-Cooler
K212657 · DWC Controller, Temperature,... · Cardiovascular
May 2022 256d
Quantum Mini Ventilation Module
K210669 · DTX Gas Control Unit,... · Cardiovascular
May 2021 60d
Quantum Ventilation Module
K202733 · DTX Gas Control Unit,... · Cardiovascular
Oct 2020 28d
Quantum Workstation 12 Elite
K202557 · DRY Monitor, Blood-gas,... · Cardiovascular
Oct 2020 29d
Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
K192838 · DWA Control, Pump Speed,... · Cardiovascular
Apr 2020 193d
Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
K190282 · DTQ Console, Heart-lung... · Cardiovascular
May 2019 102d
Quantum Ventilation Module
K181942 · DTX Gas Control Unit,... · Cardiovascular
Oct 2018 90d
Quantum Workstation 12.1
K181923 · DRY Monitor, Blood-gas,... · Cardiovascular
Aug 2018 30d
Quantum Pump Console
K173834 · DTQ Console, Heart-lung... · Cardiovascular
May 2018 158d
Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas
K173591 · DRY Monitor, Blood-gas,... · Cardiovascular
Mar 2018 127d
Quantum Workstation
K163657 · DRY Monitor, Blood-gas,... · Cardiovascular
Jan 2017 26d
M3 MONITOR
K091908 · DRY Monitor, Blood-gas,... · Cardiovascular
Jul 2009 15d
M3 MONITOR
K072131 · DRY Monitor, Blood-gas,... · Cardiovascular
Aug 2007 15d
M2 MONITOR
K071725 · DRY Monitor, Blood-gas,... · Cardiovascular
Jul 2007 16d
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