The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Siemens-elema Ab Aga Revivator.
| Device ID | K822213 |
| 510k Number | K822213 |
| Device Name: | SIEMENS-ELEMA AB AGA REVIVATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | SIEMENS ELEMA AB 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-26 |
| Decision Date | 1982-10-28 |