Otsuka Digital Feedback Device-RW— 510(k) K223463
Substantially EquivalentOtsuka America Pharmaceutical, Inc.
FDA 510(k) clearance K223463 for Otsuka Digital Feedback Device-RW, Substantially Equivalent on 2023-08-11. Applicant: Otsuka America Pharmaceutical, Inc.. Device class: 2.
Clearance details
- Applicant
- Otsuka America Pharmaceutical, Inc.
- Product code
- Code OZW
- Device class
- Class 2
- Regulation
- 21 CFR 880.6305
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockville, MD, US
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