The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Bageasy(r) Iii Adult Disposable Manual Resuscitator.
| Device ID | K934310 |
| 510k Number | K934310 |
| Device Name: | BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Richard G Confer |
| Correspondent | Richard G Confer RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-01 |
| Decision Date | 1993-12-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20709078622353 | K934310 | 000 |
| 10709078008075 | K934310 | 000 |
| 20709078048368 | K934310 | 000 |
| 00709078620133 | K934310 | 000 |
| 00709078620409 | K934310 | 000 |
| 00709078620416 | K934310 | 000 |
| 20709078620489 | K934310 | 000 |
| 20709078621363 | K934310 | 000 |
| 20709078622001 | K934310 | 000 |
| 20709078622339 | K934310 | 000 |
| 10709078008068 | K934310 | 000 |