Device Classification Name |
Analyzer, Gas, Oxygen, Gaseous-Phase
|
510(k) Number |
K951038 |
Device Name |
OXYCHECK OXYGEN MONITOR |
Applicant |
OXYCHECK, INC. |
454 WASHINGTON ST. |
NORWELL,
MA
02061
|
|
Applicant Contact |
GERRY BERKELAAR |
Correspondent |
OXYCHECK, INC. |
454 WASHINGTON ST. |
NORWELL,
MA
02061
|
|
Correspondent Contact |
GERRY BERKELAAR |
Regulation Number | 868.1720
|
Classification Product Code |
|
Date Received | 03/07/1995 |
Decision Date | 01/11/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|