MICRO H2— 510(k) K963376

Substantially Equivalent

Micro Direct, Inc.

FDA 510(k) clearance K963376 for MICRO H2, Substantially Equivalent on 1997-01-24. Applicant: Micro Direct, Inc.. Device class: 1.

Clearance details

Applicant: Micro Direct, Inc.
Product code: Code NRH
Device class: Class 1
Regulation: 21 CFR 862.1820
Advisory panel: Clinical Chemistry
Date received: 1996-08-27
Decision date: 1997-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auburn, ME, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NRH

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K874892 — VITALOGRAPH-EC60 HYDROGEN MONITOR1988-06-02

More clearances from Micro Direct, Inc.

K031102 — MICROLAB SPIROMETER2003-12-01
K030586 — MICROPEAK2003-08-27
K973314 — SPIROSAFE FILTER1997-11-21
K965042 — MICRODL DIARYCARD SPIROMETER1997-06-17
K963035 — MICRO SPIROMETER1996-11-01

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