THE CDI(R) SYSTEM 400— 510(k) K890113
Substantially EquivalentCardiovascular Devices, Inc.
FDA 510(k) clearance K890113 for THE CDI(R) SYSTEM 400, Substantially Equivalent on 1989-05-23. Applicant: Cardiovascular Devices, Inc.. Device class: 1.
Clearance details
- Applicant
- Cardiovascular Devices, Inc.
- Product code
- Code DJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.2230
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code DJY
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