The following data is part of a premarket notification filed by Puritan-bennett with the FDA for Disposable Manual Resuscitator.
| Device ID | K943617 |
| 510k Number | K943617 |
| Device Name: | DISPOSABLE MANUAL RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | PURITAN-BENNETT 10800 PFLUMM RD. Lenexa,, KS 66215 |
| Contact | C. Marshall Smith |
| Correspondent | C. Marshall Smith PURITAN-BENNETT 10800 PFLUMM RD. Lenexa,, KS 66215 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-27 |
| Decision Date | 1994-08-11 |