SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER

Chamber, Hyperbaric

PERRY BAROMEDICAL CORP.

The following data is part of a premarket notification filed by Perry Baromedical Corp. with the FDA for Sigma 3400 Monoplace Hyperbaric Chamber.

Pre-market Notification Details

Device IDK990927
510k NumberK990927
Device Name:SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER
ClassificationChamber, Hyperbaric
Applicant PERRY BAROMEDICAL CORP. 3660 INTERSTATE PKWY. Rivera Beach,  FL  33404
ContactJames P Dodson
CorrespondentJames P Dodson
PERRY BAROMEDICAL CORP. 3660 INTERSTATE PKWY. Rivera Beach,  FL  33404
Product CodeCBF  
CFR Regulation Number868.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-19
Decision Date1999-11-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00852678007108 K990927 000
00852678007092 K990927 000
00852678007085 K990927 000
00852678007030 K990927 000
00852678007023 K990927 000
00852678007016 K990927 000

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