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510(k) K940320

AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS by Ad-Tech Medical Instrument Corp — Product Code BTQ

K940320 is an FDA 510(k) premarket notification submitted by Ad-Tech Medical Instrument Corp for the device "AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS". The FDA issued a decision of Substantially Equivalent on September 19, 1995. The device falls under product code BTQ (Airway, Nasopharyngeal), a Class I device regulated under 21 CFR 868.5100. Ad-Tech Medical Instrument Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1995
Date Received
January 24, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airway, Nasopharyngeal
Device Class
Class I
Regulation Number
868.5100
Review Panel
AN
Submission Type

Other clearances by Ad-Tech Medical Instrument Corp

  • K112094 — BRAIN BIOPSY NEEDLE (April 24, 2012)
  • K053363 — DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRA (May 30, 2006)
  • K053358 — DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTROD (May 25, 2006)
  • K041604 — MACRO-MICRO DEPTH ELECTRODE (August 16, 2004)
  • K990788 — AD-TECH'S FORAMEN OVALE ELECTRODE (November 2, 1999)
  • K992194 — CORTICAL MAPPING UNIT, MODEL CMU (September 13, 1999)
  • K973454 — AD-TECH'S SPINAL ELECTRODE (June 10, 1998)
  • K970587 — AD-TECH SUBDURAL ELECTRODE (May 9, 1997)
  • K964644 — AD-TECH'S DEPTH ELECTRODE (May 9, 1997)
  • K944061 — CUEVA CRANIAL NERVE ELECTRODE (January 20, 1995)

Other clearances for product code BTQ

  • K921353 — NASOPHARYNGEAL AIRWAY (June 11, 1992)
  • K911784 — NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY (September 23, 1991)
  • K903618 — ROBERTAZZI NASOPHARYNGEAL AIRWAY (January 8, 1991)
  • K900456 — POLAMEDCO NASOPAHARYNGEAL AIRWAY (April 19, 1990)
  • K901279 — CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY (March 28, 1990)
  • K883668 — SUNDERLAND NASAL TUBE (November 21, 1988)
  • K873949 — RORERTAZZI NASOPHARYNGEAL AIRWAY (October 20, 1987)
  • K871673 — NASOPHARYNGEAL AIRWAY (June 15, 1987)
  • K853162 — STERILE NASOPHARYNGEAL AIRWAY (August 6, 1985)
  • K850644 — NASOPHARYNGEAL AIRWAY-ROBERTAZZI (March 21, 1985)

FDA data resources