SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR— 510(k) K884464

Name: FDA 510(k) clearance K884464
Creator: U.S. Food and Drug Administration
Published: 1989-01-19

Substantially Equivalent

Spirometrics, Inc.

FDA 510(k) clearance K884464 for SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR, Substantially Equivalent on 1989-01-19. Applicant: Spirometrics, Inc.. Device class: 2.

Clearance details

Applicant: Spirometrics, Inc.
Product code: Code JAX
Device class: Class 2
Regulation: 21 CFR 868.2550
Advisory panel: Anesthesiology
Date received: 1988-10-24
Decision date: 1989-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auburn, ME, US

Download summary PDF View on FDA.gov ↗

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