QUANTASCOPE— 510(k) K870442

Name: FDA 510(k) clearance K870442
Creator: U.S. Food and Drug Administration
Published: 1987-08-11

Substantially Equivalent for Some Indications

Vital Science Corp.

FDA 510(k) clearance K870442 for QUANTASCOPE, Substantially Equivalent for Some Indications on 1987-08-11. Applicant: Vital Science Corp.. Device class: 2.

Clearance details

Applicant: Vital Science Corp.
Product code: Code DXR
Device class: Class 2
Regulation: 21 CFR 870.2320
Advisory panel: Cardiovascular
Date received: 1987-02-03
Decision date: 1987-08-11
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

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