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510(k) K863134

MULTISPIRO SA/100 by Biotrine Corp. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1986
Date Received
August 15, 1986
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 Biotrine Corp.

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  • K883704 — MULTIICHALLENGE NEBULIZER SYSTEM (November 28, 1988)
  • K844226 — B-1000 (November 20, 1984)
  • K813414 — PEAK FLOW MONITOR (December 31, 1981)
  • K812825 — FLO-COR I (October 26, 1981)

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