STAR SYNC, MODIFICATION

Ventilator, Continuous, Facility Use

INFRASONICS CORP.

The following data is part of a premarket notification filed by Infrasonics Corp. with the FDA for Star Sync, Modification.

Pre-market Notification Details

Device IDK913972
510k NumberK913972
Device Name:STAR SYNC, MODIFICATION
ClassificationVentilator, Continuous, Facility Use
Applicant INFRASONICS CORP. 9944 BARNES CANYON RD. San Diego,  CA  92121
ContactJim Hitchin
CorrespondentJim Hitchin
INFRASONICS CORP. 9944 BARNES CANYON RD. San Diego,  CA  92121
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-09-05
Decision Date1992-01-09

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