The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Resusci-bag-valve.
| Device ID | K791468 |
| 510k Number | K791468 |
| Device Name: | RESUSCI-BAG-VALVE |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | CONCEPT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-06 |
| Decision Date | 1979-08-22 |