SIMS INTERTECH HYPERINFLATION BAG SYSTEM

Resuscitator, Manual, Non Self-inflating

INTERTECH RESOURCES, INC.

The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for Sims Intertech Hyperinflation Bag System.

Pre-market Notification Details

Device IDK952214
510k NumberK952214
Device Name:SIMS INTERTECH HYPERINFLATION BAG SYSTEM
ClassificationResuscitator, Manual, Non Self-inflating
Applicant INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers,  FL  33905
ContactAvia Toney
CorrespondentAvia Toney
INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers,  FL  33905
Product CodeNHK  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-11
Decision Date1995-06-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30351688436225 K952214 000
30351688404217 K952214 000
30351688404439 K952214 000
30351688405788 K952214 000
30351688406440 K952214 000
30351688406860 K952214 000
30351688411758 K952214 000
30351688413677 K952214 000
30351688416401 K952214 000
30351688416838 K952214 000
30351688425434 K952214 000
30351688425441 K952214 000
30351688434672 K952214 000
30351688403272 K952214 000

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