MICRODELTA, GATED SINGLE PHOTON (SPECT) PACKAGE— 510(k) K900892

Substantially Equivalent

Siemens Gammasonics, Inc.

FDA 510(k) clearance K900892 for MICRODELTA, GATED SINGLE PHOTON (SPECT) PACKAGE, Substantially Equivalent on 1990-05-02. Applicant: Siemens Gammasonics, Inc.. Device class: 2.

Clearance details

Applicant
Siemens Gammasonics, Inc.
Product code
Code KPS
Device class
Class 2
Regulation
21 CFR 892.1200
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hoffman Estates, IL, US
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