The following data is part of a premarket notification filed by Devilbiss Health Care, Inc. with the FDA for Devilbiss Model 5650 Pulmo-aide.
| Device ID | K923888 |
| 510k Number | K923888 |
| Device Name: | DEVILBISS MODEL 5650 PULMO-AIDE |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset, PA 15501 -0635 |
| Contact | Richard J Kocinski |
| Correspondent | Richard J Kocinski DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset, PA 15501 -0635 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-04 |
| Decision Date | 1993-02-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885304002505 | K923888 | 000 |
| 00885304002482 | K923888 | 000 |
| 10885304000928 | K923888 | 000 |
| 10885304000904 | K923888 | 000 |
| 10885304000898 | K923888 | 000 |
| 00885304000884 | K923888 | 000 |
| 10885304000874 | K923888 | 000 |