DR300 Holter Monitor
FDA 510(k) K142424 · North East Monitoring, Inc.
510(k) numberK142424
Submission
- Device name
- DR300 Holter Monitor
- Applicant
- North East Monitoring, Inc.
Maynard, MA, US - Received
- August 29, 2014
- Decision date
- November 25, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MWJ – Electrocardiograph, Ambulatory (Without Analysis)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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More from Medicalgorithmics S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K081861 | Holter LX AnalysisMNR · Traditional | 12/04/2008SE |
| K070014 | Auto Detect for Telaheart DR200/E-AMWJ · Traditional | 05/25/2007SE |
| K061293 | Telaheart Digital RecorderMWJ · Abbreviated | 08/25/2006SE |
| K041901 | SD360 Digital RECORDER/SD360 Holter Digital RecorderMWJ · Abbreviated | 08/31/2004SE |
| K004007 | DR180+OXYDSH · Special | 01/25/2001SE |
| K001288 | DR180-IIMWJ · Abbreviated | 07/20/2000SE |
| K983576 | DR180-R/OXYFLL · Traditional | 03/23/1999SE |
| K960925 | Northeast Monitoring DR180DSH · Traditional | 07/31/1996SE |
| K930564 | Holter for WindowsDQK · Traditional | 04/19/1995SE |
Questions and answers
When was DR300 Holter Monitor cleared by the FDA?
DR300 Holter Monitor (K142424) received a 510(k) decision of Substantially Equivalent on November 25, 2014, 88 days after the submission was received.
What is the product code of K142424?
The FDA product code is MWJ – Electrocardiograph, Ambulatory (Without Analysis), a Class II (moderate risk) device regulated under 21 CFR 870.2800.