Acuity Central Monitoring Station or Acuity Central Monitoring System, Mobile Acuity LT, Mobile Acuity, Mobile LT
FDA 510(k) K120774 · Welch Allyn, Inc.
510(k) numberK120774
Submission
- Device name
- Acuity Central Monitoring Station or Acuity Central Monitoring System, Mobile Acuity LT, Mobile Acuity, Mobile LT
- Applicant
- Welch Allyn, Inc.
Skaneateles Falls, NY, US - Received
- March 14, 2012
- Decision date
- April 10, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…MHX · Special | 06/30/2017SE |
| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor CoreMWI · Traditional | 12/19/2014SE |
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Questions and answers
When was Acuity Central Monitoring Station or Acuity Central Monitoring System, Mobile Acuity LT, Mobile Acuity, Mobile LT cleared by the FDA?
Acuity Central Monitoring Station or Acuity Central Monitoring System, Mobile Acuity LT, Mobile Acuity, Mobile LT (K120774) received a 510(k) decision of Substantially Equivalent on April 10, 2012, 27 days after the submission was received.
What is the product code of K120774?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.