FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Otsuka Digital Feedback Device
K Number: K251088
·
Decision Jun 30, 2025
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
7
Applicant Total
3
Review Days
82
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Basic Information
- Device Name
- Otsuka Digital Feedback Device
- K Number
- K251088
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6305
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Otsuka America Pharmaceutical, Inc.
- Date Received
- April 9, 2025
- Decision Date
- June 30, 2025
- Product Code
- OZW
- Advisory Committee
- General Hospital
- Review Advisory Committee
- CV
- 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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