The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Esprit Ventilator With Af531 Se Full Face Mask.
| Device ID | K101129 |
| 510k Number | K101129 |
| Device Name: | ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Contact | Zita A Yurko |
| Correspondent | Zita A Yurko RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-22 |
| Decision Date | 2010-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959043916 | K101129 | 000 |
| 00606959007291 | K101129 | 000 |
| 30606959007339 | K101129 | 000 |
| 30606959007346 | K101129 | 000 |
| 30606959007353 | K101129 | 000 |
| 00606959007451 | K101129 | 000 |
| 00606959007468 | K101129 | 000 |
| 00606959007475 | K101129 | 000 |
| 40606959008463 | K101129 | 000 |
| 00606959007284 | K101129 | 000 |
| 00606959007277 | K101129 | 000 |
| 00606959007062 | K101129 | 000 |
| 00606959043923 | K101129 | 000 |
| 00606959043930 | K101129 | 000 |
| 00606959043947 | K101129 | 000 |
| 30606959048097 | K101129 | 000 |
| 00606959048102 | K101129 | 000 |
| 00606959007031 | K101129 | 000 |
| 00606959007048 | K101129 | 000 |
| 00606959007055 | K101129 | 000 |
| 40606959008470 | K101129 | 000 |
| 30606959008480 | K101129 | 000 |
| 30606959012296 | K101129 | 000 |
| 30606959012302 | K101129 | 000 |
| 30606959012319 | K101129 | 000 |
| 30606959012326 | K101129 | 000 |
| 30606959012333 | K101129 | 000 |
| 00606959021051 | K101129 | 000 |
| 00606959021068 | K101129 | 000 |
| 00606959021075 | K101129 | 000 |
| 30606959012289 | K101129 | 000 |
| 30606959012128 | K101129 | 000 |
| 30606959012111 | K101129 | 000 |
| 30606959008497 | K101129 | 000 |
| 30606959008688 | K101129 | 000 |
| 30606959008695 | K101129 | 000 |
| 30606959008701 | K101129 | 000 |
| 30606959012074 | K101129 | 000 |
| 30606959012081 | K101129 | 000 |
| 30606959012098 | K101129 | 000 |
| 30606959012104 | K101129 | 000 |
| 00606959021082 | K101129 | 000 |