REAL Immersive System
FDA 510(k) K183296 · Penumbra, Inc.
510(k) numberK183296
Submission
- Device name
- REAL Immersive System
- Applicant
- Penumbra, Inc.
Alameda, CA, US - Received
- November 27, 2018
- Decision date
- March 18, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ISD – Exerciser, Measuring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5360
- Specialty
- Physical Medicine
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Questions and answers
When was REAL Immersive System cleared by the FDA?
REAL Immersive System (K183296) received a 510(k) decision of Substantially Equivalent on March 18, 2019, 111 days after the submission was received.
What is the product code of K183296?
The FDA product code is ISD – Exerciser, Measuring, a Class II (moderate risk) device regulated under 21 CFR 890.5360.