Cleared Abbreviated

K062098 - SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX
(FDA 510(k) Clearance)

K062098 · Datascope Corp. · Cardiovascular
Feb 2007
Decision
196d
Days
Class 2
Risk

K062098 is an FDA 510(k) clearance for the SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX).

Submitted by Datascope Corp. (Mahwah, US). The FDA issued a Cleared decision on February 5, 2007, 196 days after receiving the submission on July 24, 2006.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K062098 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2006
Decision Date February 05, 2007
Days to Decision 196 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

Similar Devices — MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 418
IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)
K252726 · Philips Medizin Systeme Boeblingen GmbH · Feb 2026
Corvair Monza
K252589 · AliveCor, Inc. · Jan 2026
Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)
K250854 · Shenzhen Comen Medical Instruments Co.,Ltd · Dec 2025
IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )
K251702 · Philips Medizin Systeme B?blingen GmbH · Nov 2025
IntelliVue Patient monitors MX400, MX450, MX500, MX550
K251146 · Philips Medizin Systeme Boeblingen GmbH · Oct 2025
IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)
K250453 · Philips Medizin Systeme B?blingen GmbH · Sep 2025