Cleared Traditional

MICRODL DIARYCARD SPIROMETER

K965042 · Micro Direct, Inc. · Anesthesiology

Jun 1997

Decision

182d

Days

Class 2

Risk

About This 510(k) Submission

K965042 is an FDA 510(k) clearance for the MICRODL DIARYCARD SPIROMETER, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Micro Direct, Inc. (Auburn, US). The FDA issued a Cleared decision on June 17, 1997, 182 days after receiving the submission on December 17, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number	K965042 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 17, 1996
Decision Date	June 17, 1997
Days to Decision	182 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF