MODEL PDEXA BONE DENSITOMETER
FDA 510(k) clearance K931996 · decided 1995-02-01
Clearance details
- K-number
- K931996
- Device name
- MODEL PDEXA BONE DENSITOMETER
- Applicant
- Norland Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-04-23
- Decision date
- 1995-02-01
- Days to decision
- 649 days
- Clearance type
- Traditional
- Product code
- KGI
- Device class
- 2
- Regulation number
- 892.1170
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Fort Atkinson, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.