K183296 is an FDA 510(k) clearance for the REAL Immersive System. This device is classified as a Exerciser, Measuring (Class II - Special Controls, product code ISD).
Submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on March 18, 2019, 111 days after receiving the submission on November 27, 2018.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5360.
| 510(k) Number | K183296 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2018 |
| Decision Date | March 18, 2019 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ISD — Exerciser, Measuring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5360 |