PFLEX TM— 510(k) K820528

Substantially Equivalent

Health Scan, Inc.

FDA 510(k) clearance K820528 for PFLEX TM, Substantially Equivalent on 1982-03-26. Applicant: Health Scan, Inc.. Device class: 2.

Clearance details

Applicant: Health Scan, Inc.
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 1982-03-01
Decision date: 1982-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.