BONE MINERAL DENSITOMETER
FDA 510(k) clearance K941362 · decided 1995-08-30
Clearance details
- K-number
- K941362
- Device name
- BONE MINERAL DENSITOMETER
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-03-21
- Decision date
- 1995-08-30
- Days to decision
- 527 days
- Clearance type
- Traditional
- Product code
- KGI
- Device class
- 2
- Regulation number
- 892.1170
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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No recalls on record reference this clearance.
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