Audicor Cor Sensor (and Accessory Adaptor)
FDA 510(k) K030316 · Inovise Medical, Inc.
510(k) numberK030316
Submission
- Device name
- Audicor Cor Sensor (and Accessory Adaptor)
- Applicant
- Inovise Medical, Inc.
Newberg, OR, US - Received
- January 30, 2003
- Decision date
- August 7, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DRX – Electrode, Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2360
- Specialty
- Cardiovascular
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More from Suzuken Co., Ltd.
| 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 |
| K073545 | Audicor, Hemo Ambulatory MonitorMWJ · Traditional | 09/09/2008SE |
| K070136 | Audicor 200 System, Models 200D and 200SDPS · Traditional | 04/13/2007SE |
| K051450 | Extended Measurements SystemDQD · Traditional | 11/10/2005SE |
Questions and answers
When was Audicor Cor Sensor (and Accessory Adaptor) cleared by the FDA?
Audicor Cor Sensor (and Accessory Adaptor) (K030316) received a 510(k) decision of Substantially Equivalent on August 7, 2003, 189 days after the submission was received.
What is the product code of K030316?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.