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510(k) K820178

PI808 MOBILE C-ARM IMAGE INTENSIFIER by Precise Optics — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1982
Date Received
January 22, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

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  • K827087 — P1808 MOBILE C-ARM IMAGE INTENSIFIER (March 4, 1982)

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