| Device Classification Name |
Laryngoscope, Non-Rigid
|
| 510(k) Number |
K850978 |
| Device Name |
OLYMPUS LF-1 INTUBATION SCOPE |
| Applicant |
| Olympus Corp. |
| 4 Nevada Dr. |
|
Lake Success,
NY
11042
|
|
| Applicant Contact |
TERRY J HARTL |
| Correspondent |
| Olympus Corp. |
| 4 Nevada Dr. |
|
Lake Success,
NY
11042
|
|
| Correspondent Contact |
TERRY J HARTL |
| Regulation Number | 868.5530 |
| Classification Product Code |
|
| Date Received | 03/08/1985 |
| Decision Date | 05/23/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|