Device Classification Name |
Ventilator, Emergency, Powered (Resuscitator)
|
510(k) Number |
K841893 |
Device Name |
MAXAMAN |
Applicant |
CRYO2 CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
CRYO2 CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 868.5925
|
Classification Product Code |
|
Date Received | 05/07/1984 |
Decision Date | 08/30/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|