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510(k) K011865

ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION by Zoll Medical Corp — Product Code DSK

K011865 is an FDA 510(k) premarket notification submitted by Zoll Medical Corp for the device "ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION". The FDA issued a decision of Substantially Equivalent on July 31, 2001. The device falls under product code DSK (Computer, Blood-Pressure), a Class II device regulated under 21 CFR 870.1110. Zoll Medical Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2001
Date Received
June 14, 2001
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 Zoll Medical Corp

  • K133484 — ZOLL X SERIES (August 1, 2014)
  • K112660 — POCKETCPR (May 10, 2012)
  • K090989 — ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES (September 23, 2009)
  • K042007 — ZOLL E SERIES DEFIBRILLATOR (April 7, 2005)
  • K042302 — ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTE (October 26, 2004)
  • K042417 — ZOLL M SERIES ETC02 LOFLO OPTION (October 5, 2004)
  • K033474 — ZOLL AED PLUS (May 21, 2004)
  • K032691 — ZOLL AUTOCLAVABLE INTERNAL HANDLES (November 13, 2003)
  • K032439 — ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) (November 5, 2003)
  • K032363 — ZOLL M SERIES NIBP OPTION (October 31, 2003)

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)
  • K003122 — SMARTFLOW, MODEL SFIP 2000 (May 14, 2001)

FDA data resources