The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Bageasy(r) Iii Child/infant Dispos Man Resuscitators.
| Device ID | K940581 |
| 510k Number | K940581 |
| Device Name: | BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS |
| 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 | 1994-02-08 |
| Decision Date | 1994-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20709078622377 | K940581 | 000 |
| 00709078562112 | K940581 | 000 |
| 00709078620805 | K940581 | 000 |
| 20709078620816 | K940581 | 000 |
| 20709078620823 | K940581 | 000 |
| 20709078620847 | K940581 | 000 |
| 20709078620861 | K940581 | 000 |
| 00709078621116 | K940581 | 000 |
| 20709078621332 | K940581 | 000 |
| 20709078621905 | K940581 | 000 |
| 20709078622032 | K940581 | 000 |
| 20709078622346 | K940581 | 000 |
| 20709078622360 | K940581 | 000 |
| 10709078013888 | K940581 | 000 |