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510(k) K213564

BiWaze Clear System by Abmrc, LLC — Product Code NHJ

K213564 is an FDA 510(k) premarket notification submitted by Abmrc, LLC for the device "BiWaze Clear System". The FDA issued a decision of Substantially Equivalent on December 21, 2022. The device falls under product code NHJ (Device, Positive Pressure Breathing, Intermittent), a Class II device regulated under 21 CFR 868.5905. Abmrc, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2022
Date Received
November 9, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Positive Pressure Breathing, Intermittent
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by Abmrc, LLC

  • K231728 — BiWaze Clear System (April 8, 2024)
  • K191912 — BiWaze Cough (March 27, 2020)

Other clearances for product code NHJ

  • K253001 — KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) (June 16, 2026)
  • K242438 — Clearo (May 16, 2025)
  • K231728 — BiWaze Clear System (April 8, 2024)
  • K200988 — Maximus System (May 26, 2020)
  • K191912 — BiWaze Cough (March 27, 2020)
  • K192143 — Maximus System (February 14, 2020)
  • K151689 — MetaNeb 4 System (March 17, 2016)
  • K140598 — PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC (October 16, 2014)
  • K140605 — MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC (October 3, 2014)
  • K132988 — VITAL COUGH (March 28, 2014)

FDA data resources