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510(k) K201764

Infinity Acute Care System (IACS) Monitoring Solution by Draeger Medical Systems, Inc. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2021
Date Received
June 29, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Draeger Medical Systems, Inc.

  • K243606 — Babyroo TN300 (January 17, 2025)
  • K240312 — Infinity CentralStation Wide (August 1, 2024)
  • K233834 — Infinity Gateway Suite (July 12, 2024)
  • K231477 — Infinity CentralStation Wide, Infinity M300, Infinity M300+ (October 17, 2023)
  • K230278 — Babyroo TN300 (May 30, 2023)
  • K203579 — Infinity Gateway Suite (June 7, 2022)
  • K203088 — Infinity Acute Care System (IACS) Monitoring System (February 1, 2022)
  • K200859 — Infinity M300 (August 28, 2020)
  • K182977 — Isolette 8000 Plus (November 21, 2018)
  • K172656 — BiliLux (May 1, 2018)

Other clearances for product code MHX

  • K252726 — IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX10 (February 6, 2026)
  • K252589 — Corvair Monza (January 9, 2026)
  • K250854 — Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); (December 17, 2025)
  • K251702 — IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4 (November 10, 2025)
  • K251146 — IntelliVue Patient monitors MX400, MX450, MX500, MX550 (October 17, 2025)
  • K250453 — IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); (September 2, 2025)
  • K250179 — Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) (July 29, 2025)
  • K242562 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (July 9, 2025)
  • K250757 — Radius VSM and Accessories (May 29, 2025)
  • K242962 — Telemetry Monitor 5500 Release 4.0 (867232) (May 5, 2025)