MICROLAB SPIROMETER— 510(k) K031102

Substantially Equivalent

Micro Direct, Inc.

FDA 510(k) clearance K031102 for MICROLAB SPIROMETER, Substantially Equivalent on 2003-12-01. Applicant: Micro Direct, Inc.. Device class: 2.

Clearance details

Applicant: Micro Direct, Inc.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2003-04-07
Decision date: 2003-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lewiston, ME, US

Download summary PDF View on FDA.gov ↗

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More clearances from Micro Direct, Inc.

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K973314 — SPIROSAFE FILTER1997-11-21
K965042 — MICRODL DIARYCARD SPIROMETER1997-06-17
K963376 — MICRO H21997-01-24

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