M-MODE ANALYSIS SYSTEM— 510(k) K822425
Substantially EquivalentUser Resources, Inc.
FDA 510(k) clearance K822425 for M-MODE ANALYSIS SYSTEM, Substantially Equivalent on 1982-10-04. Applicant: User Resources, Inc.. Device class: 2.
Clearance details
- Applicant
- User Resources, Inc.
- Product code
- Code DXK
- Device class
- Class 2
- Regulation
- 21 CFR 870.2330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code DXK
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