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510(k) K860949

DUAL-AID by Vitalograph , Ltd. — Product Code CAE

K860949 is an FDA 510(k) premarket notification submitted by Vitalograph , Ltd. for the device "DUAL-AID". The FDA issued a decision of Substantially Equivalent on May 6, 1986. The device falls under product code CAE (Airway, Oropharyngeal, Anesthesiology), a Class I device regulated under 21 CFR 868.5110. Vitalograph , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1986
Date Received
March 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airway, Oropharyngeal, Anesthesiology
Device Class
Class I
Regulation Number
868.5110
Review Panel
AN
Submission Type

Other clearances by Vitalograph , Ltd.

  • K253293 — VitaloJAK Clinic (Model 7100) (December 3, 2025)
  • K000599 — VITALOGRAPH BASE STATION (September 8, 2000)
  • K991412 — VITALOGRAPH MICRO (February 4, 2000)
  • K943678 — ELECTRONIC FLOW METER (December 14, 1995)
  • K950854 — VITALOGRAPH 2110 SOFTWARE INTERFACE (October 12, 1995)
  • K946075 — VITALOGRAPH MODEL 2120 (August 4, 1995)
  • K942779 — DISPOSABLE BACTERIOLOGICAL FILTER (July 13, 1994)
  • K925085 — ESCORT SPIROMETER (August 12, 1993)
  • K930085 — VITALOGRAPH DATA STORAGE SPIROMETER (July 26, 1993)
  • K912412 — VITALOGRAPH SPIROTRAC III (October 15, 1991)

Other clearances for product code CAE

  • K130304 — LMA FAMILY OF AIRWAYS (May 30, 2014)
  • K033189 — KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 30 (May 4, 2004)
  • K033186 — KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 (April 14, 2004)
  • K021634 — KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 (January 9, 2003)
  • K955721 — CUFFED OROPHARYNGEAL AIRWAY (COPA) (March 28, 1997)
  • K960240 — RUSCH OPTOSAFE (April 19, 1996)
  • K950613 — KEISEI (February 14, 1996)
  • K953400 — GUEDEL AIRWAY (October 24, 1995)
  • K933760 — STB GUEDEL AIRWAY (March 23, 1994)
  • K936134 — BERMAN AIRWAY (January 28, 1994)

FDA data resources