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510(k) K003688

VIEW READING STATION by Electromed Intl., Ltd. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2001
Date Received
November 30, 2000
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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  • K875342 — EDEC 90C (January 29, 1988)
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  • K870851 — EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR (March 20, 1987)

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