PEGASYS NUCLEAR MEDICINE IMAGING COMPUTER— 510(k) K892358

Name: FDA 510(k) clearance K892358
Creator: U.S. Food and Drug Administration
Published: 1989-08-23

Substantially Equivalent

Adac Laboratories

FDA 510(k) clearance K892358 for PEGASYS NUCLEAR MEDICINE IMAGING COMPUTER, Substantially Equivalent on 1989-08-23. Applicant: Adac Laboratories. Device class: 2.

Clearance details

Applicant: Adac Laboratories
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1989-04-06
Decision date: 1989-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, US

Download summary PDF View on FDA.gov ↗

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