Discovery NM 750b Bopsy— 510(k) K160933

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K160933 for Discovery NM 750b Bopsy, Substantially Equivalent on 2016-11-18. Applicant: GE Healthcare. Device class: 1.

Clearance details

Applicant
GE Healthcare
Product code
Code IYX
Device class
Class 1
Regulation
21 CFR 892.1100
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tirat Hacarmel, IL
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