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510(k) K952880

MODEL LP-1000 VOLUME VENTILATOR by Aequitron Medical, Inc. — Product Code CBK

Clearance Details

Decision
ST ()
Decision Date
June 20, 1996
Date Received
June 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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  • K903020 — RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 (April 10, 1991)
  • K903010 — CONTINUOUS VOLUME VENTILATOR MODEL LP10 (November 30, 1990)
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  • K902785 — MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON (July 13, 1990)
  • K901656 — MODEL 9200 RESPIRATION/HEART RATE MONITOR (July 13, 1990)

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