ELITE— 510(k) K812538
Substantially EquivalentBiotone International, Inc.
FDA 510(k) clearance K812538 for ELITE, Substantially Equivalent on 1981-12-01. Applicant: Biotone International, Inc.. Device class: 2.
Clearance details
- Applicant
- Biotone International, Inc.
- Product code
- Code IPF
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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