HR-2000 W/SUFFIXES B,C,D, CARDIO & DIGI LOOP, DDVP— 510(k) K882175
Substantially EquivalentEigen
FDA 510(k) clearance K882175 for HR-2000 W/SUFFIXES B,C,D, CARDIO & DIGI LOOP, DDVP, Substantially Equivalent on 1988-08-19. Applicant: Eigen. Device class: 2.
Clearance details
- Applicant
- Eigen
- Product code
- Code JAA
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nevada City, CA, US
Recent devices under product code JAA
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view allAdverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.