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510(k) K854333

BIOCHEM 515 RESPIRATION MONITOR by Biochem International, Inc. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1986
Date Received
October 28, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Breathing Frequency
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

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  • K901861 — BIOCHEM 9100 MULTIGAS MONITOR (July 27, 1990)
  • K893877 — BIOCHEM 3100 OXIMETER (December 20, 1989)
  • K892646 — BIOCHEM 8100 ANESTHETIC AGENT MONITOR (August 31, 1989)

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