K003499 is an FDA 510(k) clearance for the REMVIEW SLEEP RECORDER, MODEL 320. This device is classified as a Device, Sleep Assessment (Class II - Special Controls, product code LEL).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on February 9, 2001, 88 days after receiving the submission on November 13, 2000.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5050.
| 510(k) Number | K003499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2000 |
| Decision Date | February 09, 2001 |
| Days to Decision | 88 days |
| Submission Type | Abbreviated |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | LEL — Device, Sleep Assessment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5050 |