Device Classification Name |
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
|
510(k) Number |
K860692 |
Device Name |
PTR MK II VENTILATOR |
Applicant |
BEAR MEDICAL SYSTEMS, INC. |
2085 RUSTIN AVE. |
RIVERSIDE,
CA
92507
|
|
Applicant Contact |
RAY PIZINGER |
Correspondent |
BEAR MEDICAL SYSTEMS, INC. |
2085 RUSTIN AVE. |
RIVERSIDE,
CA
92507
|
|
Correspondent Contact |
RAY PIZINGER |
Regulation Number | 868.5935
|
Classification Product Code |
|
Date Received | 02/25/1986 |
Decision Date | 05/21/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|