| Device Classification Name |
System, Communication, Powered
|
| 510(k) Number |
K923819 |
| Device Name |
EEC-1 PACKAGE |
| Applicant |
| Med Labs, Inc. |
| 28 Vereda Cordillera |
|
Goleta,
CA
93117
|
|
| Applicant Contact |
PHILIP D NORVELL |
| Correspondent |
| Med Labs, Inc. |
| 28 Vereda Cordillera |
|
Goleta,
CA
93117
|
|
| Correspondent Contact |
PHILIP D NORVELL |
| Regulation Number | 890.3710 |
| Classification Product Code |
|
| Date Received | 07/30/1992 |
| Decision Date | 11/06/1992 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|