| Device Classification Name |
Ventilator, Continuous, Facility Use
|
| 510(k) Number |
K905234 |
| Device Name |
TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES |
| Applicant |
| PERCUSSIONAIRE CORP. |
| BIRD AIRLODGE, GLENGARY BAY |
| P.O. BOX 817 |
|
SANDPOINT,
ID
83864
|
|
| Applicant Contact |
FORREST M BIRD |
| Correspondent |
| PERCUSSIONAIRE CORP. |
| BIRD AIRLODGE, GLENGARY BAY |
| P.O. BOX 817 |
|
SANDPOINT,
ID
83864
|
|
| Correspondent Contact |
FORREST M BIRD |
| Regulation Number | 868.5895 |
| Classification Product Code |
|
| Date Received | 11/07/1990 |
| Decision Date | 06/13/1991 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
| Recalls |
CDRH Recalls
|
|
|