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510(k) K203579

Infinity Gateway Suite by Draeger Medical Systems, Inc. — Product Code MSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2022
Date Received
December 7, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Network And Communication, Physiological Monitors
Device Class
Class II
Regulation Number
870.2300
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)
  • K203088 — Infinity Acute Care System (IACS) Monitoring System (February 1, 2022)
  • K201764 — Infinity Acute Care System (IACS) Monitoring Solution (December 9, 2021)
  • K200859 — Infinity M300 (August 28, 2020)
  • K182977 — Isolette 8000 Plus (November 21, 2018)
  • K172656 — BiliLux (May 1, 2018)

Other clearances for product code MSX

  • K243270 — TigerConnect Alarm Management (September 30, 2025)
  • K242728 — BeneVision Central Monitoring System (July 31, 2025)
  • K242750 — Central Station (June 5, 2025)
  • K242842 — ANNE View, Central Hub (January 8, 2025)
  • K241397 — Hinscope (November 14, 2024)
  • K233834 — Infinity Gateway Suite (July 12, 2024)
  • K233418 — Biofourmis Everion+ (G2) (May 9, 2024)
  • K232548 — Corsano CardioWatch 287-2 System (March 22, 2024)
  • K231506 — Current Health System (August 24, 2023)
  • K223567 — CNS-2101 Central Monitor (July 31, 2023)