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510(k) K021517

ABP FOR WINDOWS by Rozinn Electronics, Inc. — Product Code DSK

K021517 is an FDA 510(k) premarket notification submitted by Rozinn Electronics, Inc. for the device "ABP FOR WINDOWS". The FDA issued a decision of Substantially Equivalent on July 24, 2002. The device falls under product code DSK (Computer, Blood-Pressure), a Class II device regulated under 21 CFR 870.1110. Rozinn Electronics, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2002
Date Received
May 10, 2002
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 Rozinn Electronics, Inc.

  • K061780 — TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS + (September 15, 2006)
  • K042463 — HOLTER PLUS (September 22, 2004)
  • K022540 — CARDIO ID+(RZ153+) (October 24, 2002)
  • K020213 — NETLINK/NETSCAN (April 5, 2002)
  • K903331 — ROZINN 151 (October 22, 1990)

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

FDA data resources