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510(k) K802184

HS10 PORTABLE OPERATING ROOM MONITOR by Medtel Pty. , Ltd. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1980
Date Received
September 10, 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)
  • K800243 — D668 & D664 CENTRAL MONITORING SYSTEMS (April 10, 1980)
  • K791838 — HSH/H512 ADULT PHYSIOLOGICAL MONITORS (October 1, 1979)
  • K791839 — H59 CRITICAL CARE MONITOR (October 1, 1979)

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