The following data is part of a premarket notification filed by Percussionaire Corp. with the FDA for Txp Transporter Family And Related Accessories.
Device ID | K905234 |
510k Number | K905234 |
Device Name: | TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES |
Classification | Ventilator, Continuous, Facility Use |
Applicant | PERCUSSIONAIRE CORP. BIRD AIRLODGE, GLENGARY BAY P.O. BOX 817 Sandpoint, ID 83864 |
Contact | Forrest M Bird |
Correspondent | Forrest M Bird PERCUSSIONAIRE CORP. BIRD AIRLODGE, GLENGARY BAY P.O. BOX 817 Sandpoint, ID 83864 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-07 |
Decision Date | 1991-06-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00849436000426 | K905234 | 000 |
00849436000204 | K905234 | 000 |
10849436000607 | K905234 | 000 |
10849436000614 | K905234 | 000 |