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510(k) K884389

MODIFIED 225/SIMV VOLUME VENTILATOR by Monaghan Medical Corp. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1990
Date Received
October 18, 1988
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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  • K955234 — TRUPEAK PEAK FLOW METER (March 18, 1996)
  • K955262 — TRUZONE PEAK FLOW METER (March 7, 1996)

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