ACCURATECARE I & ACCURATECARE II— 510(k) K851511
Substantially EquivalentSunnex, Inc.
FDA 510(k) clearance K851511 for ACCURATECARE I & ACCURATECARE II, Substantially Equivalent on 1985-07-01. Applicant: Sunnex, Inc.. Device class: 2.
Clearance details
- Applicant
- Sunnex, Inc.
- Product code
- Code GZJ
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elk Grove Village, IL, US
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