K111885 is an FDA 510(k) clearance for the SIMPLYGO PORTABLE OXYGEN CONCENTRATOR. This device is classified as a Generator, Oxygen, Portable (Class II - Special Controls, product code CAW).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on November 4, 2011, 126 days after receiving the submission on July 1, 2011.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K111885 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2011 |
| Decision Date | November 04, 2011 |
| Days to Decision | 126 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CAW — Generator, Oxygen, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5440 |