The following data is part of a premarket notification filed by Owens-brigam Medical Co. with the FDA for Manual Resuscitator.
| Device ID | K963848 |
| 510k Number | K963848 |
| Device Name: | MANUAL RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | OWENS-BRIGAM MEDICAL CO. 65 HANES RD. Newland, NC 28657 |
| Contact | Bill Brooks |
| Correspondent | Bill Brooks OWENS-BRIGAM MEDICAL CO. 65 HANES RD. Newland, NC 28657 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-25 |
| Decision Date | 1997-07-07 |
| Summary: | summary |