Cardiovise ECG Interpretative Software
FDA 510(k) K001349 · Inovise Medical, Inc.
510(k) numberK001349
Submission
- Device name
- Cardiovise ECG Interpretative Software
- Applicant
- Inovise Medical, Inc.
Newberg, OR, US - Received
- April 28, 2000
- Decision date
- July 27, 2000
- 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 |
| K253562 | medilogFDMWJ · Traditional | Schiller AG | 08/14/2026SE |
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| K252839 | ZywieZ3 Sensor & AdhesiveMWJ · Traditional | Zywie, Inc. | 06/18/2026SE |
| 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 |
| K210758 | Q PatchMWJ · Traditional | Medicalgorithmics S.A. | 06/02/2022SE |
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Questions and answers
When was Cardiovise ECG Interpretative Software cleared by the FDA?
Cardiovise ECG Interpretative Software (K001349) received a 510(k) decision of Substantially Equivalent on July 27, 2000, 90 days after the submission was received.
What is the product code of K001349?
The FDA product code is MWJ – Electrocardiograph, Ambulatory (Without Analysis), a Class II (moderate risk) device regulated under 21 CFR 870.2800.