MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM

Computer, Oxygen-uptake

AMETEK/THERMOX INSTRUMENTS DIVISION

The following data is part of a premarket notification filed by Ametek/thermox Instruments Division with the FDA for Moxus Or Ocm-1 Oxygen Uptake System.

Pre-market Notification Details

Device IDK874663
510k NumberK874663
Device Name:MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM
ClassificationComputer, Oxygen-uptake
Applicant AMETEK/THERMOX INSTRUMENTS DIVISION 150 FREEPORT RD. Pittsburgh,  PA  15238
ContactRichard W Wanek
CorrespondentRichard W Wanek
AMETEK/THERMOX INSTRUMENTS DIVISION 150 FREEPORT RD. Pittsburgh,  PA  15238
Product CodeBZL  
CFR Regulation Number868.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-13
Decision Date1988-05-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B9671503000 K874663 000

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