DR180-II
FDA 510(k) K001288 · North East Monitoring, Inc.
510(k) numberK001288
Submission
- Device name
- DR180-II
- Applicant
- North East Monitoring, Inc.
Sudbury, MA, US - Received
- April 24, 2000
- Decision date
- July 20, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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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| K253529 | Peerbridge COR MDx (Cor MDx)MWJ · Abbreviated | Peerbridge Health, Inc. | 09/04/2026SE |
| K253562 | medilogFDMWJ · Traditional | Schiller AG | 08/14/2026SE |
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| K252839 | ZywieZ3 Sensor & AdhesiveMWJ · Traditional | Zywie, Inc. | 06/18/2026SE |
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| K212317 | Eclipse MINI Model 98900MWJ · Traditional | Spacelabs Healthcare, Ltd. | 11/07/2022SE |
| K222017 | BiotresMWJ · Special | Biotricity | 07/28/2022SE |
| K210758 | Q PatchMWJ · Traditional | Medicalgorithmics S.A. | 06/02/2022SE |
More from Medicalgorithmics S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K142424 | DR300 Holter MonitorMWJ · Traditional | 11/25/2014SE |
| 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 |
| 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 DR180-II cleared by the FDA?
DR180-II (K001288) received a 510(k) decision of Substantially Equivalent on July 20, 2000, 87 days after the submission was received.
What is the product code of K001288?
The FDA product code is MWJ – Electrocardiograph, Ambulatory (Without Analysis), a Class II (moderate risk) device regulated under 21 CFR 870.2800.