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510(k) K820399

HS20 PORT. OPERATING ROOM MONITOR by Medtel Pty. , Ltd. — Product Code DRT

K820399 is an FDA 510(k) premarket notification submitted by Medtel Pty. , Ltd. for the device "HS20 PORT. OPERATING ROOM MONITOR". The FDA issued a decision of Substantially Equivalent on March 22, 1982. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Medtel Pty. , Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1982
Date Received
February 11, 1982
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)
  • 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)
  • K791838 — HSH/H512 ADULT PHYSIOLOGICAL MONITORS (October 1, 1979)

Other clearances for product code DRT

  • K261286 — The Circadia C300 System (C300) (May 20, 2026)
  • K252676 — The Circadia C300 System (C300) (February 3, 2026)
  • K253388 — Sleepiz One+ (Model 2.5) (January 28, 2026)
  • K251364 — Sleepiz One+ (2.5) (July 29, 2025)
  • 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)

FDA data resources