The following data is part of a premarket notification filed by Respironics Inc. with the FDA for Kangaroo Nasal Mask.
| Device ID | K122847 |
| 510k Number | K122847 |
| Device Name: | KANGAROO NASAL MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESPIRONICS INC. 1001 MURRY RIDGE LANE Murrysville, PA 15668 |
| Contact | Michelle Brinker |
| Correspondent | Michelle Brinker RESPIRONICS INC. 1001 MURRY RIDGE LANE Murrysville, PA 15668 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-18 |
| Decision Date | 2013-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959021471 | K122847 | 000 |
| 00606959041905 | K122847 | 000 |
| 00606959041899 | K122847 | 000 |
| 00606959041882 | K122847 | 000 |
| 00606959041875 | K122847 | 000 |
| 00606959041868 | K122847 | 000 |
| 00606959041851 | K122847 | 000 |
| 00606959040281 | K122847 | 000 |
| 00606959037403 | K122847 | 000 |
| 00606959041912 | K122847 | 000 |
| 00606959041929 | K122847 | 000 |
| 00606959021464 | K122847 | 000 |
| 00606959014428 | K122847 | 000 |
| 00606959014404 | K122847 | 000 |
| 00606959012936 | K122847 | 000 |
| 00606959012929 | K122847 | 000 |
| 00606959047150 | K122847 | 000 |
| 00606959046726 | K122847 | 000 |
| 00606959041936 | K122847 | 000 |
| 00606959037397 | K122847 | 000 |