The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Dmr Plus Disposable Manual Resuscitator.
| Device ID | K973419 |
| 510k Number | K973419 |
| Device Name: | DMR PLUS DISPOSABLE MANUAL RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Contact | Sheryll A Mathews |
| Correspondent | Sheryll A Mathews NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-10 |
| Decision Date | 1998-03-25 |
| Summary: | summary |