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510(k) K813414

PEAK FLOW MONITOR by Biotrine Corp. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
December 7, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Peak Flow, Spirometry
Device Class
Class II
Regulation Number
868.1860
Review Panel
AN
Submission Type

Other clearances by Biotrine Corp.

  • K915060 — ASTECH HOME PEAK FLOW METER (September 11, 1992)
  • K883704 — MULTIICHALLENGE NEBULIZER SYSTEM (November 28, 1988)
  • K863134 — MULTISPIRO SA/100 (December 15, 1986)
  • K844226 — B-1000 (November 20, 1984)
  • K812825 — FLO-COR I (October 26, 1981)

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