OMNICORDER, MODEL 464
FDA 510(k) clearance K990027 · decided 1999-02-09
Clearance details
- K-number
- K990027
- Device name
- OMNICORDER, MODEL 464
- Applicant
- Del Mar Avionics
- Decision
- Substantially Equivalent
- Date received
- 1999-01-05
- Decision date
- 1999-02-09
- Days to decision
- 35 days
- Clearance type
- Abbreviated
- Product code
- DSH
- Device class
- 2
- Regulation number
- 870.2800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.