Home / 510(k) Clearances / K830914

510(k) K830914

EXTERNAL VALVE FUNCTION BLOCK by Honeywell, Inc. — Product Code DRQ

K830914 is an FDA 510(k) premarket notification submitted by Honeywell, Inc. for the device "EXTERNAL VALVE FUNCTION BLOCK". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code DRQ (Amplifier And Signal Conditioner, Transducer Signal), a Class II device regulated under 21 CFR 870.2060. Honeywell, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1983
Date Received
March 24, 1983
Clearance Type
Traditional
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 Honeywell, Inc.

  • K902230 — COLORADO COLOR IMAGING RECORDER (June 19, 1990)
  • K863100 — CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR (February 3, 1987)
  • K853501 — HONEYWELL ELECTRONIC VENTILATOR EV-A (April 4, 1986)
  • K855125 — PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM (March 26, 1986)
  • K851888 — APM DISPOS. BLOOD PRESSURE TRANSDUCER (August 6, 1985)
  • K851496 — ECG MONITOR MODEL RM102 (July 24, 1985)
  • K850794 — PATIENT MONITOR MODEL RM-300 (April 18, 1985)
  • K851092 — PORTABLE DEFIBRILLATOR/MONITOR ED 425 (April 10, 1985)
  • K834530 — EXTENSION BOX EB200 (June 1, 1984)
  • K834282 — ULTRA IMAGER 2000 (April 23, 1984)

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)
  • K033807 — INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER (March 9, 2004)
  • 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)

FDA data resources