The following data is part of a premarket notification filed by Molecular Products Ltd. with the FDA for Rogs.
| Device ID | K131016 |
| 510k Number | K131016 |
| Device Name: | ROGS |
| Classification | Generator, Oxygen, Portable |
| Applicant | MOLECULAR PRODUCTS LTD. 24301 WOODSAGE DR. Bonita Springs, FL 34134 -2958 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden MOLECULAR PRODUCTS LTD. 24301 WOODSAGE DR. Bonita Springs, FL 34134 -2958 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-11 |
| Decision Date | 2013-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060031380019 | K131016 | 000 |