510(k) K183296
K183296 is an FDA 510(k) premarket notification submitted by Penumbra, Inc. for the device "REAL Immersive System". The FDA issued a decision of Substantially Equivalent on March 18, 2019. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360. Penumbra, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 2019
- Date Received
- November 27, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Exerciser, Measuring
- Device Class
- Class II
- Regulation Number
- 890.5360
- Review Panel
- PM
- Submission Type