The following data is part of a premarket notification filed by Respironics Inc., Sleep & Home Respiratory Group with the FDA for Gas Transfill.
| Device ID | K091191 |
| 510k Number | K091191 |
| Device Name: | GAS TRANSFILL |
| Classification | Generator, Oxygen, Portable |
| Applicant | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1740 GOLDEN MILE HWY Monroeville, PA 15146 |
| Contact | Zita A Yurko |
| Correspondent | Zita A Yurko RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1740 GOLDEN MILE HWY Monroeville, PA 15146 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-23 |
| Decision Date | 2009-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959044241 | K091191 | 000 |
| 00606959032507 | K091191 | 000 |
| 00606959032491 | K091191 | 000 |
| 00606959032477 | K091191 | 000 |