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510(k) K870703

SKAN D-SCOPE by Medx, Inc. — Product Code IYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1987
Date Received
February 20, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Scintillation (Gamma)
Device Class
Class I
Regulation Number
892.1100
Review Panel
RA
Submission Type

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  • K896553 — MEDX CERVICAL EXTENSION TEST & REHAB MACHINE (January 2, 1990)
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  • K884661 — D-SCOPE III (April 12, 1989)
  • K872127 — D-SCOPE II AND D-SCOPE IIC (June 18, 1987)

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