The following data is part of a premarket notification filed by Engineered Medical Systems with the FDA for Baxter Adult/pedi/infant Single Use Man Resuscit.
| Device ID | K924610 |
| 510k Number | K924610 |
| Device Name: | BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | ENGINEERED MEDICAL SYSTEMS 8529 ZIONSVILLE RD. P.O. BOX 681514 Indianapolis, IN 46268 |
| Contact | Jeff Quinn |
| Correspondent | Jeff Quinn ENGINEERED MEDICAL SYSTEMS 8529 ZIONSVILLE RD. P.O. BOX 681514 Indianapolis, IN 46268 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-11 |
| Decision Date | 1993-04-06 |