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510(k) K002833

MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER by Standard Imaging, Inc. — Product Code KPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2000
Date Received
September 12, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Dose, Radionuclide
Device Class
Class II
Regulation Number
892.1360
Review Panel
RA
Submission Type

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  • K940539 — STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM (March 16, 1994)
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