EPICARDIA 4000
FDA 510(k) clearance K900207 · decided 1990-07-31
Clearance details
- K-number
- K900207
- Device name
- EPICARDIA 4000
- Applicant
- Medicomp, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-01-16
- Decision date
- 1990-07-31
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- DST
- Device class
- 2
- Regulation number
- 870.3260
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- West Melbourne, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.