The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Bipap A 30 Ventilatory Support System.
| Device ID | K113053 |
| 510k Number | K113053 |
| Device Name: | BIPAP A 30 VENTILATORY SUPPORT SYSTEM |
| Classification | Ventilator, Continuous, Non-life-supporting |
| Applicant | RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Contact | Elaine Larkin |
| Correspondent | Elaine Larkin RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Product Code | MNS |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-13 |
| Decision Date | 2012-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959021532 | K113053 | 000 |
| 00606959039377 | K113053 | 000 |
| 00606959039360 | K113053 | 000 |
| 00606959039353 | K113053 | 000 |
| 00606959039346 | K113053 | 000 |
| 00606959039339 | K113053 | 000 |
| 00606959039322 | K113053 | 000 |
| 00606959039315 | K113053 | 000 |
| 00606959039308 | K113053 | 000 |
| 00606959047938 | K113053 | 000 |
| 00606959056923 | K113053 | 000 |
| 00606959054691 | K113053 | 000 |
| 00606959048768 | K113053 | 000 |
| 00606959048751 | K113053 | 000 |
| 00606959039384 | K113053 | 000 |
| 00606959039391 | K113053 | 000 |
| 00606959039407 | K113053 | 000 |
| 00606959049635 | K113053 | 000 |
| 00606959045231 | K113053 | 000 |
| 00606959042728 | K113053 | 000 |
| 00606959042711 | K113053 | 000 |
| 00606959042704 | K113053 | 000 |
| 00606959042698 | K113053 | 000 |
| 00606959042681 | K113053 | 000 |
| 00606959042674 | K113053 | 000 |
| 00606959042667 | K113053 | 000 |
| 00606959039452 | K113053 | 000 |
| 00606959039445 | K113053 | 000 |
| 00606959039421 | K113053 | 000 |
| 00606959039414 | K113053 | 000 |
| 00606959048744 | K113053 | 000 |