The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Baxter Nebulizer Cap Model 2d0868.
| Device ID | K962161 |
| 510k Number | K962161 |
| Device Name: | BAXTER NEBULIZER CAP MODEL 2D0868 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | BAXTER HEALTHCARE CORP. 40178 U.S. 19 NORTH Tarpon Springs, FL 34689 |
| Contact | Ed Ransom |
| Correspondent | Ed Ransom BAXTER HEALTHCARE CORP. 40178 U.S. 19 NORTH Tarpon Springs, FL 34689 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-04 |
| Decision Date | 1996-08-15 |
| Summary: | summary |