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510(k) K181219

OptiPillows EPAP Mask by Cpapnea Medical Supply — Product Code LWF

K181219 is an FDA 510(k) premarket notification submitted by Cpapnea Medical Supply for the device "OptiPillows EPAP Mask". The FDA issued a decision of Substantially Equivalent on August 3, 2018. 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
August 3, 2018
Date Received
May 7, 2018
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

  • 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)
  • K962698 — ACUTEK'S CLEARPASAGE (September 9, 1996)
  • K962400 — AIR MAX EXTERNAL NASAL DILATOR STRIP (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