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510(k) K963035

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1996
Date Received
August 5, 1996
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

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  • K963376 — MICRO H2 (January 24, 1997)
  • K950197 — MICROCO (October 17, 1996)
  • K940375 — MICRO MPM (November 21, 1994)

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