CARDIAC PROBE
FDA 510(k) clearance K760595 · decided 1976-09-17
Clearance details
- K-number
- K760595
- Device name
- CARDIAC PROBE
- Applicant
- G.D. Searle and Co.
- Decision
- Substantially Equivalent
- Date received
- 1976-09-07
- Decision date
- 1976-09-17
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- IZD
- Device class
- 1
- Regulation number
- 892.1320
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- 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.