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510(k) K915060

ASTECH HOME PEAK FLOW METER by Biotrine Corp. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1992
Date Received
November 8, 1991
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.

  • K883704 — MULTIICHALLENGE NEBULIZER SYSTEM (November 28, 1988)
  • K863134 — MULTISPIRO SA/100 (December 15, 1986)
  • K844226 — B-1000 (November 20, 1984)
  • K813414 — PEAK FLOW MONITOR (December 31, 1981)
  • K812825 — FLO-COR I (October 26, 1981)

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