Cleared Traditional

COROMETRICS MEDICAL SYSTEMS 220 PH SYS.

K800271 · Transidyne General Corp. · Chemistry
Feb 1980
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K800271 is an FDA 510(k) clearance for the COROMETRICS MEDICAL SYSTEMS 220 PH SYS., a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Transidyne General Corp. (Mchenry, US). The FDA issued a Cleared decision on February 26, 1980, 20 days after receiving the submission on February 6, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K800271 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 1980
Decision Date February 26, 1980
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1120

Similar Devices — CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

All 186
i-STAT CG4+ cartridge with the i-STAT 1 System
K244014 · Abbott Point of Care, Inc. · May 2025
ABL90 FLEX PLUS System
K240998 · Radiometer Medicals Aps · Dec 2024
i-STAT CG8+ cartridge with the i-STAT 1 System
K230285 · Abbott Point of Care, Inc. · Oct 2023
Stat Profile Prime Plus Analyzer System
K221900 · Nova Biomedical Corporation · Sep 2023
i-STAT G3+ cartridge with the i-STAT 1 System
K223857 · Abbott Point of Care, Inc. · Sep 2023
GEM Premier 7000 with IQM3
K223608 · Instrumentation Laboratory Company · Aug 2023