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510(k) K870851

EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR by Electromed Intl., Ltd. — Product Code IZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1987
Date Received
March 3, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, High-Voltage, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1700
Review Panel
RA
Submission Type

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  • K945453 — UD 150L-R II (March 21, 1995)