PEAK FLOW MONITOR— 510(k) K915059

Substantially Equivalent

Spirometrics, Inc.

FDA 510(k) clearance K915059 for PEAK FLOW MONITOR, Substantially Equivalent on 1992-07-27. Applicant: Spirometrics, Inc.. Device class: 2.

Clearance details

Applicant: Spirometrics, Inc.
Product code: Code BZH
Device class: Class 2
Regulation: 21 CFR 868.1860
Advisory panel: Anesthesiology
Date received: 1991-11-08
Decision date: 1992-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auburn, ME, US

Download summary PDF View on FDA.gov ↗

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More clearances from Spirometrics, Inc.

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K884464 — SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR1989-01-19

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