BREAST-SCAN(TM)
FDA 510(k) clearance K872962 · decided 1987-10-20
Clearance details
- K-number
- K872962
- Device name
- BREAST-SCAN(TM)
- Applicant
- Thermascan, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-07-29
- Decision date
- 1987-10-20
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- LHM
- Device class
- 1
- Regulation number
- 884.2982
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.