EVALUATOR #9500 DYNAMIC ELEC/SCANNER
FDA 510(k) clearance K801831 · decided 1980-09-09
Clearance details
- K-number
- K801831
- Device name
- EVALUATOR #9500 DYNAMIC ELEC/SCANNER
- Applicant
- Del Mar Avionics
- Decision
- Substantially Equivalent
- Date received
- 1980-08-01
- Decision date
- 1980-09-09
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- DSI
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.