The following data is part of a premarket notification filed by B & B Medical Technologies, Inc. with the FDA for Mini Heart.
| Device ID | K923690 |
| 510k Number | K923690 |
| Device Name: | MINI HEART |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | B & B MEDICAL TECHNOLOGIES, INC. 3569 RECYCLE RD., SUITE 16 Rancho Cordova, CA 95670 |
| Contact | Briggs Ii |
| Correspondent | Briggs Ii 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 | 1992-07-24 |
| Decision Date | 1992-10-20 |