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510(k) K881266

MODEL 9216 RESPIRATION/HEART RATE MONITOR by Aequitron Medical, Inc. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1988
Date Received
March 24, 1988
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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  • 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)

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