CARDIAC VIEW, MODEL 2001— 510(k) K010802

Substantially Equivalent

Magna Lab, Inc.

FDA 510(k) clearance K010802 for CARDIAC VIEW, MODEL 2001, Substantially Equivalent on 2001-06-08. Applicant: Magna Lab, Inc.. Device class: 2.

Clearance details

Applicant
Magna Lab, Inc.
Product code
Code MOS
Device class
Class 2
Regulation
21 CFR 892.1000
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Newton, MA, US
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