SPIROMETRICS 2453 & SMI III— 510(k) K850045

Substantially Equivalent

Spirometrics, Inc.

FDA 510(k) clearance K850045 for SPIROMETRICS 2453 & SMI III, Substantially Equivalent on 1985-02-14. Applicant: Spirometrics, Inc.. Device class: 2.

Clearance details

Applicant: Spirometrics, Inc.
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 1985-01-07
Decision date: 1985-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Spirometrics, Inc.

K915059 — PEAK FLOW MONITOR1992-07-27
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K901057 — SPIROMETRICS MODEL 2600 MIRO SPIROMETER1990-04-03

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