The following data is part of a premarket notification filed by Chesebrough-pond's U.s.a. Co. with the FDA for Exerciser, Air-eze Incentive.
| Device ID | K781833 |
| 510k Number | K781833 |
| Device Name: | EXERCISER, AIR-EZE INCENTIVE |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | CHESEBROUGH-POND'S U.S.A. CO. 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 | 1978-10-30 |
| Decision Date | 1978-11-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704626513 | K781833 | 000 |
| 24026704596977 | K781833 | 000 |