MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR— 510(k) K011439
Substantially EquivalentCardiodynamics International Corp.
FDA 510(k) clearance K011439 for MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR, Substantially Equivalent on 2001-11-02. Applicant: Cardiodynamics International Corp.. Device class: 2.
Clearance details
- Applicant
- Cardiodynamics International Corp.
- 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
- San Diego, CA, US
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