COLOR DOPPLER 880— 510(k) K843643
Substantially EquivalentIrex Corp.
FDA 510(k) clearance K843643 for COLOR DOPPLER 880, Substantially Equivalent on 1985-01-31. Applicant: Irex Corp.. Device class: 2.
Clearance details
- Applicant
- Irex Corp.
- 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
- Ramsey, NJ, US
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