Audicor, Hemo Ambulatory Monitor
FDA 510(k) K073545 · Inovise Medical, Inc.
510(k) numberK073545
Submission
- Device name
- Audicor, Hemo Ambulatory Monitor
- Applicant
- Inovise Medical, Inc.
Portland, OR, US - Received
- December 18, 2007
- Decision date
- September 9, 2008
- 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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| K253529 | Peerbridge COR MDx (Cor MDx)MWJ · Abbreviated | Peerbridge Health, Inc. | 09/04/2026SE |
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| K231424 | HeartBeam AIMIGo(TM) SystemMWJ · Traditional | Heartbeam, Inc. | 12/13/2024SE |
| K233864 | ASSURE Wearable ECGMWJ · Traditional | Kestra Medical Technologies, Inc. | 05/07/2024SE |
| K212317 | Eclipse MINI Model 98900MWJ · Traditional | Spacelabs Healthcare, Ltd. | 11/07/2022SE |
| K222017 | BiotresMWJ · Special | Biotricity | 07/28/2022SE |
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More from Medicalgorithmics S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K151433 | AUDICOR CA300/CC100 Analyzer with SDBMNR · Traditional | 03/18/2016SE |
| K131883 | Audicor Cpam with SDB (Accelerometer Based)MNR · Traditional | 04/11/2014SE |
| K130660 | Audicor Cpam with SDB (Single Sensor)MLO · Traditional | 10/11/2013SE |
| K120462 | Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…MLO · Traditional | 09/20/2012SE |
| K110569 | Audicor Cpam (Cardiopulmonary Ambulatory Monitor)MLO · Traditional | 10/24/2011SE |
| K103516 | Audicor Sensor-Adapter Model Audicor Sensor-Adapter 4.0DQD · Traditional | 02/04/2011SE |
| K080602 | Audicor Sensor, Models: 2.0, 3.0DRX · Traditional | 09/25/2008SE |
| K070136 | Audicor 200 System, Models 200D and 200SDPS · Traditional | 04/13/2007SE |
| K051450 | Extended Measurements SystemDQD · Traditional | 11/10/2005SE |
| K043074 | Liberty SystemDPS · Traditional | 02/22/2005SE |
Questions and answers
When was Audicor, Hemo Ambulatory Monitor cleared by the FDA?
Audicor, Hemo Ambulatory Monitor (K073545) received a 510(k) decision of Substantially Equivalent on September 9, 2008, 266 days after the submission was received.
What is the product code of K073545?
The FDA product code is MWJ – Electrocardiograph, Ambulatory (Without Analysis), a Class II (moderate risk) device regulated under 21 CFR 870.2800.