FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
PROTEUS INGESTION CONFINMATION SYSTEMS
K Number: DEN120011
·
Decision Jul 10, 2012
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
7
Applicant Total
2
Review Days
60
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Basic Information
- Device Name
- PROTEUS INGESTION CONFINMATION SYSTEMS
- K Number
- DEN120011
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 880.6305
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Applicant
- Proteus Biomedical, Inc.
- Date Received
- May 11, 2012
- Decision Date
- July 10, 2012
- 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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Other Clearances by Proteus Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K093976 | RAISIN PERSONAL MONITOR | Mar 25, 2010 | Substantially Equivalent |