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510(k) K031102

MICROLAB SPIROMETER by Micro Direct, Inc. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2003
Date Received
April 7, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type

Other clearances by Micro Direct, Inc.

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  • K965042 — MICRODL DIARYCARD SPIROMETER (June 17, 1997)
  • K963376 — MICRO H2 (January 24, 1997)
  • K963035 — MICRO SPIROMETER (November 1, 1996)
  • K950197 — MICROCO (October 17, 1996)
  • K940375 — MICRO MPM (November 21, 1994)

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