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510(k) K874089

BREATHE WITH EEZ (NASAL DILATOR) by Breathe With Eez Corp. — Product Code LWF

K874089 is an FDA 510(k) premarket notification submitted by Breathe With Eez Corp. for the device "BREATHE WITH EEZ (NASAL DILATOR)". The FDA issued a decision of Substantially Equivalent on December 23, 1987. The device falls under product code LWF (Dilator, Nasal), a Class I device regulated under 21 CFR 874.3900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1987
Date Received
October 7, 1987
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 for product code LWF

  • K181219 — OptiPillows EPAP Mask (August 3, 2018)
  • K120665 — INVENT SNORING DEVICE (June 12, 2012)
  • 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)

FDA data resources