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510(k) K884312

ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 by Atomic Products Corp. — Product Code KPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1989
Date Received
October 13, 1988
Clearance Type
Traditional
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

Other clearances by Atomic Products Corp.

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  • K904187 — ECONOMY C-ARM TABLE, MODEL # 056-005 (November 29, 1990)
  • K904623 — RADIOGRAPHIC TRANSPORT, TRAUMA MODEL 056-230, 235 (November 6, 1990)
  • K900851 — DIGITAL IMAGE ENHANCEMENT SYSTEM (May 11, 1990)
  • K895799 — RECTILINEAR SCANNER MODEL #187-270 (February 1, 1990)
  • K871868 — VENTI-SCAN II (April 11, 1988)
  • K874332 — MRI STRETCHER (January 5, 1988)
  • K790835 — DYNAJECT (June 22, 1979)

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