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510(k) K160239

TAP 3, TAP 1 by Airway Management, Inc. — Product Code PLC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2016
Date Received
February 1, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleep Appliances With Patient Monitoring
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy.

Other clearances by Airway Management, Inc.

  • K181482 — myTAP2 (August 31, 2018)
  • K122350 — TAP PAP NASAL PILLOW MASK (November 1, 2012)
  • K062951 — TAP III ANTI-SNORING DEVICE (December 12, 2006)
  • K061732 — TAP-T (July 12, 2006)
  • K060388 — TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT (May 17, 2006)

Other clearances for product code PLC

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  • K233497 — Rest Assure System (October 3, 2024)
  • K190353 — Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac (April 10, 2020)
  • K181571 — OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor (April 19, 2019)
  • K172859 — Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device (November 22, 2017)
  • K170606 — Acrylic Herbst Appliance with Micro-Recorder (November 16, 2017)
  • K161624 — MicrO2 OSA Device with Micro-Recorder (November 7, 2016)
  • K150369 — SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac M (June 18, 2015)