The following data is part of a premarket notification filed by B & F Medical Products, Inc. with the FDA for Incent-o-neb.
| Device ID | K781731 |
| 510k Number | K781731 |
| Device Name: | INCENT-O-NEB |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | B & F MEDICAL PRODUCTS, 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 | 1978-10-12 |
| Decision Date | 1978-12-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() INCENT-O-NEB 73206003 not registered Dead/Abandoned |
B & F MEDICAL PRODUCTS COMPANY 0000-00-00 |