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510(k) K012712

NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 by Norav Medical , Ltd. — Product Code MLO

K012712 is an FDA 510(k) premarket notification submitted by Norav Medical , Ltd. for the device "NORAV HOLTER SYSTEM, MODEL NH-300 V1.07". The FDA issued a decision of Substantially Equivalent on May 8, 2002. The device falls under product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm), a Class II device regulated under 21 CFR 870.2800. Norav Medical , Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2002
Date Received
August 14, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Norav Medical , Ltd.

  • K161062 — NR Recorder (June 13, 2016)
  • K111487 — NH-301 AMBULATORY ECG ANALYSIS SOFTWARE (November 10, 2011)
  • K110463 — PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) (November 10, 2011)
  • K080141 — PC ECG 1200W SYSTEM (April 25, 2008)
  • K000404 — PC ECG 1200 (November 22, 2000)

Other clearances for product code MLO

  • K241890 — Philips Holter Analysis System (March 21, 2025)
  • K240794 — Frontier X Plus (November 8, 2024)
  • K200833 — RX-1 Rhythm Express Remote Cardiac Monitoring System (September 2, 2020)
  • K193177 — CER-S (August 26, 2020)
  • K182030 — Faros Mobile (November 8, 2018)
  • K140847 — CARDIOSPY ECG HOLTER SYSTEMS (December 5, 2014)
  • K131897 — CV3000 HOLTER ANALYSIS SYSTEM (November 26, 2013)
  • K130660 — AUDICOR CPAM WITH SDB (SINGLE SENSOR) (October 11, 2013)
  • K120462 — AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED (September 20, 2012)
  • K111487 — NH-301 AMBULATORY ECG ANALYSIS SOFTWARE (November 10, 2011)

FDA data resources