The following data is part of a premarket notification filed by J. H. Emerson Co. with the FDA for Oxygen Powered Resuscitator For Cpr.
| Device ID | K920910 |
| 510k Number | K920910 |
| Device Name: | OXYGEN POWERED RESUSCITATOR FOR CPR |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | J. H. EMERSON CO. 22 COTTAGE PARK AVE. Cambridge, MA 02140 -1691 |
| Contact | George P Emerson |
| Correspondent | George P Emerson J. H. EMERSON CO. 22 COTTAGE PARK AVE. Cambridge, MA 02140 -1691 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-27 |
| Decision Date | 1993-01-12 |