PRIME ZOOM STRETCHER

Stretcher, Wheeled, Powered

STRYKER CORPORATION

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Prime Zoom Stretcher.

Pre-market Notification Details

Device IDK140095
510k NumberK140095
Device Name:PRIME ZOOM STRETCHER
ClassificationStretcher, Wheeled, Powered
Applicant STRYKER CORPORATION 3800 E. CENTRE AVE Portage,  MI  49002
ContactMatthew W Jordan
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeINK  
CFR Regulation Number890.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2014-01-14
Decision Date2014-05-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327278323 K140095 000
07613327278316 K140095 000
07613327278293 K140095 000
07613327278286 K140095 000

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