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510(k) K852771

PC INTERFACE by Siemens Elema AB — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1985
Date Received
June 27, 1985
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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  • K872278 — SIEMENS O2-AIR MIXER 965 (September 3, 1987)
  • K871354 — SERVO VENTILATOR 900 C/D (July 21, 1987)

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