Home / 510(k) Clearances / K834078

510(k) K834078

SILICONE RUGGER DISPOSABLE YOKE-CPAP by Vesta, Inc. — Product Code BTQ

K834078 is an FDA 510(k) premarket notification submitted by Vesta, Inc. for the device "SILICONE RUGGER DISPOSABLE YOKE-CPAP". The FDA issued a decision of Substantially Equivalent on December 27, 1983. The device falls under product code BTQ (Airway, Nasopharyngeal), a Class I device regulated under 21 CFR 868.5100. Vesta, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1983
Date Received
November 28, 1983
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 Vesta, Inc.

  • K810960 — NASOPHARYNGEAL AIRWAY (April 23, 1981)
  • K792719 — 3 WAY URETHRAL IRRIGATION CATHETER (January 16, 1980)
  • K792018 — SILICONE RUBBER-BI NASOPHARYNGEAL AIR (November 13, 1979)

Other clearances for product code BTQ

  • K940320 — AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS (September 19, 1995)
  • 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)

FDA data resources