| Device Classification Name |
Lamp, Infrared, Therapeutic Heating
|
| 510(k) Number |
K922900 |
| Device Name |
INFRARED LAMP |
| Applicant |
| Harrier, Inc. |
| Westside Towers, Suite 1000 |
| 11845 W. Olympic Blvd. |
|
Los Angeles,
CA
90084
|
|
| Applicant Contact |
JAY GELLER |
| Correspondent |
| Harrier, Inc. |
| Westside Towers, Suite 1000 |
| 11845 W. Olympic Blvd. |
|
Los Angeles,
CA
90084
|
|
| Correspondent Contact |
JAY GELLER |
| Regulation Number | 890.5500 |
| Classification Product Code |
|
| Date Received | 06/16/1992 |
| Decision Date | 11/24/1992 |
| 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
|
|
|