FUTREX-5000A— 510(k) K922601
Substantially EquivalentFutrex, Inc.
FDA 510(k) clearance K922601 for FUTREX-5000A, Substantially Equivalent on 1995-12-28. Applicant: Futrex, Inc.. Device class: 2.
Clearance details
- Applicant
- Futrex, Inc.
- Product code
- Code DSB
- Device class
- Class 2
- Regulation
- 21 CFR 870.2770
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gaithersburg, MD, US
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