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510(k) K062088

PREMIER 11 HOLTER by Diagnostic Monitoring Software — Product Code MLO

K062088 is an FDA 510(k) premarket notification submitted by Diagnostic Monitoring Software for the device "PREMIER 11 HOLTER". The FDA issued a decision of Substantially Equivalent on August 25, 2006. The device falls under product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm), a Class II device regulated under 21 CFR 870.2800. Diagnostic Monitoring Software has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2006
Date Received
July 24, 2006
Clearance Type
Special
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 Diagnostic Monitoring Software

  • K133014 — DMS 300-2W HOLTER ECG RECORDER (May 19, 2014)
  • K062959 — DMS 300-2, 300-3 AND 300-4 (October 16, 2006)
  • K062007 — DMS 300-7 (August 16, 2006)
  • K911615 — HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300 (January 8, 1992)

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