The following data is part of a premarket notification filed by Schiff & Co. with the FDA for Plus Reusable Resuscitator.
| Device ID | K974141 |
| 510k Number | K974141 |
| Device Name: | PLUS REUSABLE RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | SCHIFF & CO. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Anne M Cesario |
| Correspondent | Anne M Cesario SCHIFF & CO. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-03 |
| Decision Date | 1998-05-21 |