The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Airlife Misty Neb Medication System W/filter.
| Device ID | K883964 |
| 510k Number | K883964 |
| Device Name: | AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | BAXTER HEALTHCARE CORP. 27200 NORTH TOURNEY RD. P.O. BOX 5900 Valencia, CA 91355 -8900 |
| Contact | A Campbell |
| Correspondent | A Campbell BAXTER HEALTHCARE CORP. 27200 NORTH TOURNEY RD. P.O. BOX 5900 Valencia, CA 91355 -8900 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-20 |
| Decision Date | 1988-11-30 |