PEGASUS AIRWAVE SYST/SPEC MATTRESS DECUBITUS ULCER

Mattress, Air Flotation, Alternating Pressure

PEGASUS AIRWAVE, INC.

The following data is part of a premarket notification filed by Pegasus Airwave, Inc. with the FDA for Pegasus Airwave Syst/spec Mattress Decubitus Ulcer.

Pre-market Notification Details

Device IDK874877
510k NumberK874877
Device Name:PEGASUS AIRWAVE SYST/SPEC MATTRESS DECUBITUS ULCER
ClassificationMattress, Air Flotation, Alternating Pressure
Applicant PEGASUS AIRWAVE, INC. PORTSMOUTH ENTERPRISE CENTRE QUARTREMAINE ROAD, PORTSMOUTH Hants Po35qt, England,  GB
ContactWelch
CorrespondentWelch
PEGASUS AIRWAVE, INC. PORTSMOUTH ENTERPRISE CENTRE QUARTREMAINE ROAD, PORTSMOUTH Hants Po35qt, England,  GB
Product CodeFNM  
CFR Regulation Number880.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-13
Decision Date1988-02-22

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