Device Classification Name |
Ventilator, Emergency, Powered (Resuscitator)
|
510(k) Number |
K944349 |
Device Name |
OXYLATOR EM-100 |
Applicant |
CPR MEDICAL DEVICES, INC. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760 -4153
|
|
Applicant Contact |
ROSINA ROBINSON |
Correspondent |
CPR MEDICAL DEVICES, INC. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760 -4153
|
|
Correspondent Contact |
ROSINA ROBINSON |
Regulation Number | 868.5925
|
Classification Product Code |
|
Date Received | 09/06/1994 |
Decision Date | 04/17/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|