Spacelabs Medical 12-LEAD Diagnostic ECG Analysis Option
FDA 510(k) K962970 · Spacelabs Medical, Inc.
510(k) numberK962970
Submission
- Device name
- Spacelabs Medical 12-LEAD Diagnostic ECG Analysis Option
- Applicant
- Spacelabs Medical, Inc.
Redmond, WA, US - Received
- July 31, 1996
- Decision date
- March 25, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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| K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0)DSI · Traditional | Boston Scientific Cardiac Diagnostic… | 01/23/2026SE |
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)DSI · Traditional | Infobionic, Inc. | 07/29/2025SE |
| K240177 | Zio AT® device (A100A1001)DSI · Traditional | iRhythm Technologies, Inc. | 10/30/2024SE |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated | Infobionic, Inc. | 10/06/2023SE |
| K231276 | SmartCardia 7L PlatformDSI · Traditional | Smartcardia SA | 08/30/2023SE |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IVDSI · Special | Medicalgorithmics S.A. | 04/09/2020SE |
| K192732 | BodyGuardian Remote Monitoring SystemDSI · Traditional | Preventice Technologies, Inc. | 03/26/2020SE |
| K190574 | Patient Assistant Model PA97000DSI · Traditional | Medtronic, Inc. | 09/24/2019SE |
| K182532 | Liba3 SystemDSI · Traditional | National Cardiac, Inc. | 05/15/2019SE |
| K181658 | MobileECG 2 BTDSI · Traditional | Memtec Corporation | 03/26/2019SE |
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Questions and answers
When was Spacelabs Medical 12-LEAD Diagnostic ECG Analysis Option cleared by the FDA?
Spacelabs Medical 12-LEAD Diagnostic ECG Analysis Option (K962970) received a 510(k) decision of Substantially Equivalent on March 25, 1997, 237 days after the submission was received.
What is the product code of K962970?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.