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510(k) K120665

INVENT SNORING DEVICE by Ventus Medical, Inc. — Product Code LWF

K120665 is an FDA 510(k) premarket notification submitted by Ventus Medical, Inc. for the device "INVENT SNORING DEVICE". The FDA issued a decision of Substantially Equivalent on June 12, 2012. The device falls under product code LWF (Dilator, Nasal), a Class I device regulated under 21 CFR 874.3900. Ventus Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2012
Date Received
March 5, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Nasal
Device Class
Class I
Regulation Number
874.3900
Review Panel
EN
Submission Type

Other clearances by Ventus Medical, Inc.

  • K102404 — PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEE (December 2, 2010)
  • K090398 — PROVENT PROFESSIONAL SLEEP APNEA THERAPY (April 3, 2009)
  • K080983 — PROVENT NASAL CANNULA (August 7, 2008)
  • K071560 — PROVENT NASAL DILATOR, MODEL BR2 (February 8, 2008)

Other clearances for product code LWF

  • K181219 — OptiPillows EPAP Mask (August 3, 2018)
  • K040491 — CHIN-UP STRIP (September 10, 2004)
  • K982929 — MAXAIR NASAL DILATOR SYSTEM (September 9, 1998)
  • K963326 — BREATHE FIT (February 12, 1997)
  • K962400 — AIR MAX EXTERNAL NASAL DILATOR STRIP (September 9, 1996)
  • K962698 — ACUTEK'S CLEARPASAGE (September 9, 1996)
  • K955711 — BREATHE RIGHT NASAL STRIP (May 30, 1996)
  • K954914 — BREATHE RIGHT NASAL STRIP (February 27, 1996)
  • K955233 — EASY BREATHING NASAL STRIPS (December 21, 1995)
  • K953042 — E-Z BREATHERS (December 8, 1995)

FDA data resources