SKYLIGHT IMAGING SYSTEM
FDA 510(k) clearance K000908 · decided 2000-04-05
Clearance details
- K-number
- K000908
- Device name
- SKYLIGHT IMAGING SYSTEM
- Applicant
- Adac Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2000-03-21
- Decision date
- 2000-04-05
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Milpitas, CA, US
- Third-party review
- Yes
- Expedited review
- No
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