510(k) K872962
- Device
- BREAST-SCAN(TM)
- Applicant
- THERMASCAN, INC.
- 510(k) number
- K872962
- Product code
- LHM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-10-20
- Date received
- 1987-07-29
- Regulation
- 884.2982
- Classification name
- System, Thermographic, Liquid Crystal
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- GYAN, PH.D.
- Address
- 500 Fifth Ave. New York NY US 10110 10110
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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