K141967 is an FDA 510(k) clearance for the PUREFILL OXYGEN COMPRESSOR. This device is classified as a Generator, Oxygen, Portable (Class II - Special Controls, product code CAW).
Submitted by Inovo, Inc. (Lehigh Acres, US). The FDA issued a Cleared decision on November 7, 2014, 109 days after receiving the submission on July 21, 2014.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K141967 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2014 |
| Decision Date | November 07, 2014 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAW — Generator, Oxygen, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5440 |