HDR 1000 PLUS WELL CHAMBER, MODEL 90008— 510(k) K060532
Substantially EquivalentStandard Imaging, Inc.
FDA 510(k) clearance K060532 for HDR 1000 PLUS WELL CHAMBER, MODEL 90008, Substantially Equivalent on 2006-04-11. Applicant: Standard Imaging, Inc.. Device class: 2.
Clearance details
- Applicant
- Standard Imaging, Inc.
- Product code
- Code JAQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5700
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Middleton, WI, US
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