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510(k) K883704

MULTIICHALLENGE NEBULIZER SYSTEM by Biotrine Corp. — Product Code BTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1988
Date Received
August 30, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Air, Portable
Device Class
Class II
Regulation Number
868.6250
Review Panel
AN
Submission Type

Other clearances by Biotrine Corp.

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  • 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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