The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Real Immersive System.
| Device ID | K183296 |
| 510k Number | K183296 |
| Device Name: | REAL Immersive System |
| Classification | Exerciser, Measuring |
| Applicant | Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Contact | Mary Rose |
| Correspondent | Mary Rose Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Product Code | ISD |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-27 |
| Decision Date | 2019-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815948022416 | K183296 | 000 |
| 00815948021389 | K183296 | 000 |
| 00815948021037 | K183296 | 000 |
| 00815948024212 | K183296 | 000 |
| 00815948024205 | K183296 | 000 |
| 00815948029484 | K183296 | 000 |
| 00815948029477 | K183296 | 000 |
| 00815948029460 | K183296 | 000 |