TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES

Ventilator, Continuous, Facility Use

PERCUSSIONAIRE CORP.

The following data is part of a premarket notification filed by Percussionaire Corp. with the FDA for Txp Transporter Family And Related Accessories.

Pre-market Notification Details

Device IDK905234
510k NumberK905234
Device Name:TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES
ClassificationVentilator, Continuous, Facility Use
Applicant PERCUSSIONAIRE CORP. BIRD AIRLODGE, GLENGARY BAY P.O. BOX 817 Sandpoint,  ID  83864
ContactForrest M Bird
CorrespondentForrest M Bird
PERCUSSIONAIRE CORP. BIRD AIRLODGE, GLENGARY BAY P.O. BOX 817 Sandpoint,  ID  83864
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-11-07
Decision Date1991-06-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00849436000426 K905234 000
00849436000204 K905234 000
10849436000607 K905234 000
10849436000614 K905234 000

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