MODIFIED LASERFLO BLOOD PERFUSION MONITOR— 510(k) K864259

Name: FDA 510(k) clearance K864259
Creator: U.S. Food and Drug Administration
Published: 1987-02-20

Substantially Equivalent

Tsi, Inc.

FDA 510(k) clearance K864259 for MODIFIED LASERFLO BLOOD PERFUSION MONITOR, Substantially Equivalent on 1987-02-20. Applicant: Tsi, Inc.. Device class: 2.

Clearance details

Applicant: Tsi, Inc.
Product code: Code DPW
Device class: Class 2
Regulation: 21 CFR 870.2100
Advisory panel: Cardiovascular
Date received: 1986-10-29
Decision date: 1987-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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