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510(k) K863431

OXYGEN CANNULA EAR WRAP (STYLE A) by Salter Labs — Product Code CAT

K863431 is an FDA 510(k) premarket notification submitted by Salter Labs for the device "OXYGEN CANNULA EAR WRAP (STYLE A)". The FDA issued a decision of Substantially Equivalent on September 18, 1986. The device falls under product code CAT (Cannula, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5340. Salter Labs has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1986
Date Received
September 4, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Nasal, Oxygen
Device Class
Class I
Regulation Number
868.5340
Review Panel
AN
Submission Type

Other clearances by Salter Labs

  • K190878 — Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-T (January 10, 2020)
  • K161719 — Salter Labs Bubble Humidifier (September 21, 2017)
  • K151874 — BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlo (April 15, 2016)
  • K151506 — Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula (March 11, 2016)
  • K151421 — Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannul (March 10, 2016)
  • K143700 — CPAP Cannulaide (August 5, 2015)
  • K142416 — Luma Wrap (June 12, 2015)
  • K092685 — PNEUMOTHERML, MODEL: 5800 (November 24, 2009)
  • K051313 — BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER (September 15, 2005)
  • K040202 — SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM (March 4, 2005)

Other clearances for product code CAT

  • K011125 — NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA M (June 13, 2001)
  • K935533 — NASAL CANNULA (February 3, 1994)
  • K922397 — 4 SURE TM NASAL OXYGEN CANNULA (March 18, 1993)
  • K921496 — SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED (August 14, 1992)
  • K920573 — CANNULA NASAL OXYGEN (August 11, 1992)
  • K913421 — NASAL OXYGEN CANNULA, 81585, 81587 & 81589 (October 18, 1991)
  • K912197 — SKIN SAVER(TM) TUBING HOLDER, MODEL 467 (August 20, 1991)
  • K911740 — SALTER LABS NEONATAL NASAL OXYGEN CANNULA (July 24, 1991)
  • K902420 — CATHETER, NASAL, OXYGEN (April 17, 1991)
  • K896036 — THE COMFORTABLE CANNULA (November 17, 1989)

FDA data resources