Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K792456 |
Device Name |
PNEUPAC VENTILATOR/RESUSCITATOR #3 |
Applicant |
PNEU PAC, LTD. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
PNEU PAC, LTD. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 12/03/1979 |
Decision Date | 02/05/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|