ACCUPEN— 510(k) K083377
Substantially EquivalentAccutome Ultrasound, Inc.
FDA 510(k) clearance K083377 for ACCUPEN, Substantially Equivalent on 2009-07-27. Applicant: Accutome Ultrasound, Inc.. Device class: 2.
Clearance details
- Applicant
- Accutome Ultrasound, Inc.
- Product code
- Code HKX
- Device class
- Class 2
- Regulation
- 21 CFR 886.1930
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
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