METAPHOR METABOLIC MONITOR

Computer, Oxygen-uptake

TREYMED, INC.

The following data is part of a premarket notification filed by Treymed, Inc. with the FDA for Metaphor Metabolic Monitor.

Pre-market Notification Details

Device IDK093080
510k NumberK093080
Device Name:METAPHOR METABOLIC MONITOR
ClassificationComputer, Oxygen-uptake
Applicant TREYMED, INC. N56 W24790 N. CORPORATE CIRCLE UNIT C Sussex,  WI  53089
ContactRobert H Ricciardelli
CorrespondentRobert H Ricciardelli
TREYMED, INC. N56 W24790 N. CORPORATE CIRCLE UNIT C Sussex,  WI  53089
Product CodeBZL  
Subsequent Product CodeBZC
Subsequent Product CodeCBR
Subsequent Product CodeCCK
Subsequent Product CodeCCL
Subsequent Product CodeDQA
CFR Regulation Number868.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-30
Decision Date2010-01-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B23133151 K093080 000
B23133141 K093080 000
B23133131 K093080 000
B23133121 K093080 000

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