2D CARDIAC SECTOR SCANNER
FDA 510(k) clearance K837097 · decided 1983-03-22
Clearance details
- K-number
- K837097
- Device name
- 2D CARDIAC SECTOR SCANNER
- Applicant
- Second Foundation, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-01-26
- Decision date
- 1983-03-22
- Days to decision
- 55 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Rancho Cordova, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.