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510(k) K791838

HSH/H512 ADULT PHYSIOLOGICAL MONITORS by Medtel Pty. , Ltd. — Product Code DSK

K791838 is an FDA 510(k) premarket notification submitted by Medtel Pty. , Ltd. for the device "HSH/H512 ADULT PHYSIOLOGICAL MONITORS". The FDA issued a decision of Substantially Equivalent on October 1, 1979. The device falls under product code DSK (Computer, Blood-Pressure), a Class II device regulated under 21 CFR 870.1110. Medtel Pty. , Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1979
Date Received
September 14, 1979
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 Medtel Pty. , Ltd.

  • K832356 — PORTABLE OPERAT. RM. MONITORS HS30/40 (October 28, 1983)
  • K820670 — HS17/HS18 SERIES MONITORS (April 9, 1982)
  • K820671 — CM10 CENTRAL MONITORING SYSTEM (April 1, 1982)
  • K820399 — HS20 PORT. OPERATING ROOM MONITOR (March 22, 1982)
  • K802184 — HS10 PORTABLE OPERATING ROOM MONITOR (September 26, 1980)
  • K800243 — D668 & D664 CENTRAL MONITORING SYSTEMS (April 10, 1980)
  • K791839 — H59 CRITICAL CARE MONITOR (October 1, 1979)

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