RESPCARE HYBRID AV MASK

Ventilator, Non-continuous (respirator)

RESPCARE INC.

The following data is part of a premarket notification filed by Respcare Inc. with the FDA for Respcare Hybrid Av Mask.

Pre-market Notification Details

Device IDK062224
510k NumberK062224
Device Name:RESPCARE HYBRID AV MASK
ClassificationVentilator, Non-continuous (respirator)
Applicant RESPCARE INC. 6601 LYONS ROAD, SUITES B1-B4 Coconut Creek,  FL  33073
ContactFrank Pelc
CorrespondentFrank Pelc
RESPCARE INC. 6601 LYONS ROAD, SUITES B1-B4 Coconut Creek,  FL  33073
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-02
Decision Date2006-08-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10607411943765 K062224 000
10607411943758 K062224 000
10607411943741 K062224 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.