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510(k) K040221

SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E by Maquet Critical Care AB — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2004
Date Received
February 2, 2004
Clearance Type
Special
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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  • K153461 — Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guid (December 11, 2015)
  • K123149 — SERVO-I VENTILATOR SYSTEM (June 20, 2014)

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