The following data is part of a premarket notification filed by B & B Medical Technologies, Inc. with the FDA for Heart Nebulizer Flowmeter Adaptor.
| Device ID | K913015 |
| 510k Number | K913015 |
| Device Name: | HEART NEBULIZER FLOWMETER ADAPTOR |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | B & B MEDICAL TECHNOLOGIES, INC. P.O. BOX 1503 Orangevale, CA 95662 |
| Contact | Stephen W Briggs |
| Correspondent | Stephen W Briggs B & B MEDICAL TECHNOLOGIES, INC. P.O. BOX 1503 Orangevale, CA 95662 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-08 |
| Decision Date | 1991-11-20 |