CARDIOCAP(TM) CMO-104 MONITOR— 510(k) K882093
Substantially EquivalentDatex Division Instrumentarium Corp.
FDA 510(k) clearance K882093 for CARDIOCAP(TM) CMO-104 MONITOR, Substantially Equivalent on 1988-07-28. Applicant: Datex Division Instrumentarium Corp.. Device class: 2.
Clearance details
- Applicant
- Datex Division Instrumentarium Corp.
- Product code
- Code DSK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1110
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Helsinki, Finland, FI
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