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510(k) K871551

MODEL NUMBER 8200 RESPIRATION/HEART RATE MONITOR by Aequitron Medical, Inc. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1987
Date Received
April 22, 1987
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

Other clearances by Aequitron Medical, Inc.

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  • K952880 — MODEL LP-1000 VOLUME VENTILATOR (June 20, 1996)
  • K944654 — OXYGEN CONCENTRATION INDICATOR (November 8, 1994)
  • K914424 — MODEL 6213 REMOTE ALARM (September 10, 1992)
  • K915381 — PORTABLE OXYGEN GENERATOR (March 11, 1992)
  • K911399 — NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) (September 19, 1991)
  • K903020 — RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 (April 10, 1991)
  • K903010 — CONTINUOUS VOLUME VENTILATOR MODEL LP10 (November 30, 1990)
  • K905244 — MODEL LP6 VENTILATOR, MODIFICATION (November 30, 1990)
  • K901656 — MODEL 9200 RESPIRATION/HEART RATE MONITOR (July 13, 1990)

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