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510(k) K781053

DINAMAP MODEL 846 by Applied Medical Research — Product Code DSK

K781053 is an FDA 510(k) premarket notification submitted by Applied Medical Research for the device "DINAMAP MODEL 846". The FDA issued a decision of Substantially Equivalent on September 7, 1978. The device falls under product code DSK (Computer, Blood-Pressure), a Class II device regulated under 21 CFR 870.1110. Applied Medical Research has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1978
Date Received
June 22, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Blood-Pressure
Device Class
Class II
Regulation Number
870.1110
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)
  • K781064 — DINAMAP MODEL 848 (September 7, 1978)
  • K781311 — ELECTRODE, NEEDLE, CFM (August 21, 1978)
  • K780754 — NEONATAL MONITOR (June 14, 1978)
  • K780759 — MODEL 902 STAND (May 19, 1978)

Other clearances for product code DSK

  • K231586 — Endophys Blood Pressure Monitor model BPM-30 (November 3, 2023)
  • K160945 — Endophys Blood Pressure Monitor (September 26, 2016)
  • K152582 — CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box (December 3, 2015)
  • K141615 — ENDOPHYS BLOOD PRESSURE MONITOR (January 7, 2015)
  • K080670 — MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (April 23, 2008)
  • K070795 — SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (August 31, 2007)
  • K033738 — MONITORING SYSTEM, MODEL ARGUS PB-2200 (August 24, 2004)
  • K021517 — ABP FOR WINDOWS (July 24, 2002)
  • K013943 — RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 (December 18, 2001)
  • K011865 — ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION (July 31, 2001)

FDA data resources