FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)
K Number: K133263
·
Decision Feb 7, 2014
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
7
Applicant Total
4
Review Days
107
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)
- K Number
- K133263
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.6305
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Proteus Digital Health, Inc.
- Date Received
- October 23, 2013
- Decision Date
- February 7, 2014
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OZW), ordered by most recent decision date.
Otsuka Digital Feedback Device
FDA 510(k)
FDA Class 2
·General Hospital
Otsuka Digital Feedback Device-RW
FDA 510(k)
FDA Class 2
·General Hospital
ID-Cap System
FDA 510(k)
FDA Class 2
·General Hospital
Proteus Digital Health Feedback Device
FDA 510(k)
FDA Class 2
·General Hospital
PROTEUS PATCH INCLUDING INGESTIBLE SENSOR
FDA 510(k)
FDA Class 2
·General Hospital
PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)
FDA 510(k)
FDA Class 2
·General Hospital