SPIRO-LINK REAL TIME SPIROMETRY SYSTEM— 510(k) K892121

Name: FDA 510(k) clearance K892121
Creator: U.S. Food and Drug Administration
Published: 1989-06-16

Substantially Equivalent

Biocom Intl., Inc.

FDA 510(k) clearance K892121 for SPIRO-LINK REAL TIME SPIROMETRY SYSTEM, Substantially Equivalent on 1989-06-16. Applicant: Biocom Intl., Inc.. Device class: 2.

Clearance details

Applicant: Biocom Intl., Inc.
Product code: Code BZC
Device class: Class 2
Regulation: 21 CFR 868.1880
Advisory panel: Anesthesiology
Date received: 1989-03-31
Decision date: 1989-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Puyallup, WA, 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.