HEARTCARD, MODEL 5258— 510(k) K010945
Substantially EquivalentInstromedix
FDA 510(k) clearance K010945 for HEARTCARD, MODEL 5258, Substantially Equivalent on 2001-06-12. Applicant: Instromedix. Device class: 2.
Clearance details
- Applicant
- Instromedix
- Product code
- Code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code DXH
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