Device Classification Name |
Computer, Oxygen-Uptake
|
510(k) Number |
K922660 |
Device Name |
PHYSIO-DYNE EASI - LAB |
Applicant |
PHYSIO-DYNE |
35 JEANETTE DR. |
MASSAPEQUA,
NY
11758
|
|
Applicant Contact |
DONALD B FALK |
Correspondent |
PHYSIO-DYNE |
35 JEANETTE DR. |
MASSAPEQUA,
NY
11758
|
|
Correspondent Contact |
DONALD B FALK |
Regulation Number | 868.1730
|
Classification Product Code |
|
Date Received | 06/03/1992 |
Decision Date | 04/08/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|