Normatec Elite— 510(k) K240122
Substantially EquivalentNormaTec Industries, LP
FDA 510(k) clearance K240122 for Normatec Elite, Substantially Equivalent on 2024-03-21. Applicant: NormaTec Industries, LP. Device class: 2.
Clearance details
- Applicant
- NormaTec Industries, LP
- Product code
- Code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Watertown, MA, US
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