VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

VACUMED, DIV. OF VACUMETRICS, INC.

The following data is part of a premarket notification filed by Vacumed, Div. Of Vacumetrics, Inc. with the FDA for Vacu*med, Gold Edition Carbon Dioxide Gas Analyzer.

Pre-market Notification Details

Device IDK973544
510k NumberK973544
Device Name:VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant VACUMED, DIV. OF VACUMETRICS, INC. 2225 EAST MURRAY HOLLADAY RD. SUITE 207 Salt Lake City,  UT  84117
ContactJacquiline E Frailey
CorrespondentJacquiline E Frailey
VACUMED, DIV. OF VACUMETRICS, INC. 2225 EAST MURRAY HOLLADAY RD. SUITE 207 Salt Lake City,  UT  84117
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-18
Decision Date1998-05-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850644007008 K973544 000

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