MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER— 510(k) K002833
Substantially EquivalentStandard Imaging, Inc.
FDA 510(k) clearance K002833 for MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER, Substantially Equivalent on 2000-09-28. Applicant: Standard Imaging, Inc.. Device class: 2.
Clearance details
- Applicant
- Standard Imaging, Inc.
- Product code
- Code KPT
- Device class
- Class 2
- Regulation
- 21 CFR 892.1360
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Middleton, WI, US
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