The following data is part of a premarket notification filed by B & B Medical Technologies, Inc. with the FDA for H.e.a.r.t. Nebulizer.
| Device ID | K900228 |
| 510k Number | K900228 |
| Device Name: | H.E.A.R.T. NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | B & B MEDICAL TECHNOLOGIES, INC. 3569 RECYCLE RD., SUITE 16 Rancho Cordova, CA 95670 |
| Contact | W Briggs,iii |
| Correspondent | W Briggs,iii B & B MEDICAL TECHNOLOGIES, INC. 3569 RECYCLE RD., SUITE 16 Rancho Cordova, CA 95670 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-17 |
| Decision Date | 1990-03-16 |