The following data is part of a premarket notification filed by Airlife, Inc. with the FDA for Air Incentive Spirometer.
| Device ID | K791819 |
| 510k Number | K791819 |
| Device Name: | AIR INCENTIVE SPIROMETER |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | AIRLIFE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-14 |
| Decision Date | 1979-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885403169357 | K791819 | 000 |
| 30889483570818 | K791819 | 000 |
| 30889483570825 | K791819 | 000 |
| 30889483570832 | K791819 | 000 |
| 30889483570849 | K791819 | 000 |
| 50190752117165 | K791819 | 000 |
| 50190752131079 | K791819 | 000 |
| 50885403131415 | K791819 | 000 |
| 50885403138179 | K791819 | 000 |
| 50885403169067 | K791819 | 000 |
| 50885403169340 | K791819 | 000 |
| 30889483570801 | K791819 | 000 |