The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Single Patient Use Disposable Manual Resuscitator.
| Device ID | K894365 |
| 510k Number | K894365 |
| Device Name: | SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
| Contact | Marshall Smith |
| Correspondent | Marshall Smith PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-14 |
| Decision Date | 1989-10-06 |