The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Nebulizer System.
| Device ID | K922623 |
| 510k Number | K922623 |
| Device Name: | NEBULIZER SYSTEM |
| Classification | Compressor, Air, Portable |
| Applicant | HEALTHDYNE, INC. 1850 PARKWAY PLACE, 12TH FLOOR Marietta, GA 30067 -8274 |
| Contact | Tim Coward |
| Correspondent | Tim Coward HEALTHDYNE, INC. 1850 PARKWAY PLACE, 12TH FLOOR Marietta, GA 30067 -8274 |
| Product Code | BTI |
| CFR Regulation Number | 868.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-02 |
| Decision Date | 1992-12-01 |