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510(k) K861707

MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR by Siemens Elema AB — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1986
Date Received
May 5, 1986
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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  • K002137 — CATHCOR DESKTOP (October 5, 2000)
  • K001315 — MODIFICATION TO KION ANESTHESIA SYSTEM (May 26, 2000)
  • K970839 — SERVO VENTILATOR 300A (October 14, 1997)
  • K960010 — SERVO VENTILATOR 300 COMPUTER INTERFACE (October 25, 1996)
  • K960168 — SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990 (October 25, 1996)
  • K872278 — SIEMENS O2-AIR MIXER 965 (September 3, 1987)
  • K871354 — SERVO VENTILATOR 900 C/D (July 21, 1987)

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