BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP— 510(k) K951770
Substantially EquivalentBiodex Medical Systems, Inc.
FDA 510(k) clearance K951770 for BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP, Substantially Equivalent on 1995-11-16. Applicant: Biodex Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Biodex Medical Systems, Inc.
- Product code
- Code IKK
- Device class
- Class 2
- Regulation
- 21 CFR 890.1925
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shirley, NY, US
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