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510(k) K192143

Maximus System by Hill-Rom Services Pte, Ltd. — Product Code NHJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2020
Date Received
August 8, 2019
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 Hill-Rom Services Pte, Ltd.

  • K200988 — Maximus System (May 26, 2020)
  • K163378 — Monarch Airway Clearance System (March 17, 2017)
  • K151689 — MetaNeb 4 System (March 17, 2016)
  • K124032 — METANEB (April 25, 2013)

Other clearances for product code NHJ

  • K242438 — Clearo (May 16, 2025)
  • K231728 — BiWaze Clear System (April 8, 2024)
  • K213564 — BiWaze Clear System (December 21, 2022)
  • K200988 — Maximus System (May 26, 2020)
  • K191912 — BiWaze Cough (March 27, 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)
  • K124032 — METANEB (April 25, 2013)