The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Airlife Electronic Incentive Spirometer.
| Device ID | K851334 |
| 510k Number | K851334 |
| Device Name: | AIRLIFE ELECTRONIC INCENTIVE SPIROMETER |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 1015 GRANDVIEW P.O. BOX 1300 Glendale, CA 91209 |
| Contact | Lawrnece W Getlin |
| Correspondent | Lawrnece W Getlin AMERICAN PHARMASEAL DIV. AHSC 1015 GRANDVIEW P.O. BOX 1300 Glendale, CA 91209 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-01 |
| Decision Date | 1985-08-06 |