The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Ab Manual Ventilation Access. 900c.
| Device ID | K841393 |
| 510k Number | K841393 |
| Device Name: | AB MANUAL VENTILATION ACCESS. 900C |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | SIEMENS ELEMA AB 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-03 |
| Decision Date | 1984-05-21 |