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510(k) K961972

MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR by Aequitron Medical, Inc. — Product Code BZQ

Clearance Details

Decision
ST ()
Decision Date
April 18, 1997
Date Received
May 20, 1996
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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  • 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)
  • K905244 — MODEL LP6 VENTILATOR, MODIFICATION (November 30, 1990)
  • K903010 — CONTINUOUS VOLUME VENTILATOR MODEL LP10 (November 30, 1990)
  • K901656 — MODEL 9200 RESPIRATION/HEART RATE MONITOR (July 13, 1990)
  • K902785 — MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON (July 13, 1990)

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