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510(k) K960544

CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM by Nasiff Assoc., Inc. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1996
Date Received
February 7, 1996
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 Nasiff Assoc., Inc.

  • K993616 — CARDIO-CARD INTERPRETATION SYSTEM I (April 10, 2000)
  • K972795 — CARDIO-CARD MANAGEMENT SYSTEM II (February 20, 1998)
  • K920020 — CARDIO-CARD ECG MANAGEMENT SYSTEM (July 9, 1992)
  • K903722 — MICROMED QRS CARD (December 5, 1990)

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  • 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)
  • K202464 — Vital Sign Monitoring Sensor (Model :XK300) (April 26, 2021)