FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REAL Immersive System
K Number: K183296
·
Decision Mar 18, 2019
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
60
Applicant Total
87
Review Days
111
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Basic Information
- Device Name
- REAL Immersive System
- K Number
- K183296
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5360
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Penumbra, Inc.
- Date Received
- November 27, 2018
- Decision Date
- March 18, 2019
- Product Code
- ISD
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ISD | Exerciser, Measuring | FDA class 2 | Physical Medicine |
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