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510(k) K844397

POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000 by Associated Mills, Inc. — Product Code DSK

K844397 is an FDA 510(k) premarket notification submitted by Associated Mills, Inc. for the device "POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000". The FDA issued a decision of Substantially Equivalent on April 18, 1985. The device falls under product code DSK (Computer, Blood-Pressure), a Class II device regulated under 21 CFR 870.1110. Associated Mills, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1985
Date Received
November 13, 1984
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 Associated Mills, Inc.

  • K901459 — DS60 TOOTHBRUSH SANITIZER (September 17, 1990)
  • K872327 — WHIRLPOOL AERATOR WB700, WB800, WB900, WB975 (September 4, 1987)
  • K871661 — WH150 ROOM HUMIDIFIER (June 15, 1987)
  • K862041 — WM10, WM20, WM30 POWER MASSAGER (June 17, 1986)
  • K862042 — SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER (June 5, 1986)
  • K844396 — POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000 (April 18, 1985)
  • K850362 — POLLENEX DIGITAL THERMOMETER T-125 (February 15, 1985)
  • K850363 — POLLENEX DIGITAL THERMOMETER T-225 (February 15, 1985)
  • K841095 — BP800, 850 1000 (August 24, 1984)
  • K841100 — HP-20, 30, 40, 50 & 60 (March 23, 1984)

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