K883591 is an FDA 510(k) clearance for the MARK-5 CONCENTRATOR. This device is classified as a Generator, Oxygen, Portable (Class II - Special Controls, product code CAW).
Submitted by Nidek Medical Products, Inc. (Birmingham, US). The FDA issued a Cleared decision on November 2, 1988, 71 days after receiving the submission on August 23, 1988.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K883591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 1988 |
| Decision Date | November 02, 1988 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | - |
| Product Code | CAW - Generator, Oxygen, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5440 |