Home / 510(k) Clearances / K780127

510(k) K780127

DINAMAP MODEL 850 by Applied Medical Research — Product Code DRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1978
Date Received
January 24, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Blood-Pressure, Extravascular
Device Class
Class II
Regulation Number
870.2850
Review Panel
CV
Submission Type

Other clearances by Applied Medical Research

  • K800025 — DINAMAP RESEARCH MONITOR 1245 (February 1, 1980)
  • K791580 — CEREBRAL FUNCTION MONITOR 870 (September 4, 1979)
  • K791159 — DINAMAP MODEL 855 (July 30, 1979)
  • K790322 — OPTIONAL ACCESSORY FOOT SWITCH MODEL 100 (May 14, 1979)
  • K790328 — MODEL 1051, MONITOR (March 2, 1979)
  • K782073 — DINAMAP MODELS 1160 AND 1165 (February 23, 1979)
  • K781053 — DINAMAP MODEL 846 (September 7, 1978)
  • K781064 — DINAMAP MODEL 848 (September 7, 1978)
  • K781311 — ELECTRODE, NEEDLE, CFM (August 21, 1978)
  • K780754 — NEONATAL MONITOR (June 14, 1978)

Other clearances for product code DRS

  • K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (March 21, 2025)
  • K221782 — Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes (March 17, 2023)
  • K172458 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw (November 9, 2017)
  • K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw (May 24, 2017)
  • K161408 — Compass Cast and MAP (November 22, 2016)
  • K152472 — Disposable Pressure Transducer (October 31, 2016)
  • K152980 — Flo Trac sensor, Volume View sensor (January 19, 2016)
  • K151040 — Art-line Single channel blood pressure system, Art-line Double channel blood pre (September 4, 2015)
  • K133624 — COMPASS CT, COMPASS CT PORT (April 18, 2014)
  • K123095 — MEDLINE BLOOD PRESSURE TRANSDUCER (May 8, 2013)