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510(k) K800243

D668 & D664 CENTRAL MONITORING SYSTEMS by Medtel Pty. , Ltd. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1980
Date Received
February 5, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
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)
  • K791838 — HSH/H512 ADULT PHYSIOLOGICAL MONITORS (October 1, 1979)
  • K791839 — H59 CRITICAL CARE MONITOR (October 1, 1979)

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  • K234003 — The Circadia C200 System (May 30, 2024)
  • K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central (March 22, 2024)
  • K231733 — Neteera 130H-Plus Vital Sign Monitoring Sensor (February 9, 2024)
  • K223163 — Sleepiz One+ (August 18, 2023)
  • K212143 — Neteera 130H/131H Vital Sign Monitoring Sensor (September 28, 2022)
  • K202138 — Cardiac Trigger Monitor (May 14, 2021)
  • K202464 — Vital Sign Monitoring Sensor (Model :XK300) (April 26, 2021)