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510(k) K945970

INSUFFLATOR FILTER TUBING SET by Xylog Corp. — Product Code FCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1994
Date Received
December 8, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Automatic Carbon-Dioxide For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Xylog Corp.

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  • K882049 — MEDITRON MG-1000 MONOPOLAR GENERATOR (August 5, 1988)
  • K874798 — MEDITRON BI-2000 BIPOLAR GENERATOR W/IRRIGATION (February 24, 1988)

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  • K132192 — BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR (February 14, 2014)
  • K123047 — BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET (August 6, 2013)