The following data is part of a premarket notification filed by Respironics Inc., Sleep & Home Respiratory Group with the FDA for Remstar Auto A-flex.
| Device ID | K091319 |
| 510k Number | K091319 |
| Device Name: | REMSTAR AUTO A-FLEX |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Zita A Yurko |
| Correspondent | Zita A Yurko RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-05 |
| Decision Date | 2009-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959004108 | K091319 | 000 |
| 00606959000957 | K091319 | 000 |
| 00606959000964 | K091319 | 000 |
| 00606959000971 | K091319 | 000 |
| 00606959000988 | K091319 | 000 |
| 00606959001015 | K091319 | 000 |
| 00606959001022 | K091319 | 000 |
| 00606959001039 | K091319 | 000 |
| 00606959001053 | K091319 | 000 |
| 00606959001060 | K091319 | 000 |
| 00606959039612 | K091319 | 000 |
| 00606959046375 | K091319 | 000 |
| 00606959046382 | K091319 | 000 |
| 00606959001046 | K091319 | 000 |
| 00606959002210 | K091319 | 000 |
| 00606959000995 | K091319 | 000 |