FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Proteus Digital Health Feedback Device
K Number: K150494
·
Decision Jun 27, 2015
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
7
Applicant Total
4
Review Days
122
Basic Information
- Device Name
- Proteus Digital Health Feedback Device
- K Number
- K150494
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6305
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PROTEUS DIGITAL HEALTH, INC.
- Date Received
- February 25, 2015
- Decision Date
- June 27, 2015
- Product Code
- OZW
- Advisory Committee
- General Hospital
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| OZW | Ingestible Event Marker | FDA class 2 | General Hospital |
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