The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Isothermal Heated Ventilator & Anesthesia Circuit.
| Device ID | K915226 |
| 510k Number | K915226 |
| Device Name: | ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | BAXTER HEALTHCARE CORP. 27200 NORTH TOURNEY RD. P.O. BOX 5900 Valencia, CA 91355 -8900 |
| Contact | Peggy Boersma |
| Correspondent | Peggy Boersma BAXTER HEALTHCARE CORP. 27200 NORTH TOURNEY RD. P.O. BOX 5900 Valencia, CA 91355 -8900 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-20 |
| Decision Date | 1993-01-12 |