Home / 510(k) Clearances / K033807

510(k) K033807

INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER by Draeger Medical Systems, Inc. — Product Code DRQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2004
Date Received
December 8, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier And Signal Conditioner, Transducer Signal
Device Class
Class II
Regulation Number
870.2060
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)
  • K201764 — Infinity Acute Care System (IACS) Monitoring Solution (December 9, 2021)
  • K200859 — Infinity M300 (August 28, 2020)
  • K182977 — Isolette 8000 Plus (November 21, 2018)

Other clearances for product code DRQ

  • K172216 — ACIST RXi Mini System (August 18, 2017)
  • K152693 — CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIG (October 21, 2015)
  • K150235 — CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARS (April 22, 2015)
  • K050006 — BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CH (May 27, 2005)
  • K050974 — DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS (April 29, 2005)
  • K013205 — MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 (July 2, 2002)
  • K020277 — SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER (February 19, 2002)
  • K010640 — SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER (March 20, 2001)
  • K913875 — BARD(R) BIOPOTENTIAL AMPLIFIER II (November 27, 1991)
  • K913110 — PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED (October 10, 1991)