SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND
FDA 510(k) clearance K837329 · decided 1983-06-07
Clearance details
- K-number
- K837329
- Device name
- SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND
- Applicant
- Carolina Medical Electronics
- Decision
- Substantially Equivalent
- Date received
- 1983-03-08
- Decision date
- 1983-06-07
- Days to decision
- 91 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- King, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.