Modification to Envoy Patient Monitor
FDA 510(k) K011784 · Mennen Medical , Ltd.
510(k) numberK011784
Submission
- Device name
- Modification to Envoy Patient Monitor
- Applicant
- Mennen Medical , Ltd.
Rehovot, IL - Received
- June 8, 2001
- Decision date
- August 16, 2001
- 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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| 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 |
More from Memtec Corporation
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| K141441 | Menntor X7DSI · Traditional | 01/09/2015SE |
| K131789 | Cerebralogik- AeegOMA · Traditional | 12/27/2013SE |
| K123792 | Horizon Xvu (FFR)DQX · Traditional | 08/30/2013SE |
| K093766 | Vitalogik 6000/6500DSI · Special | 05/07/2010SE |
| K091165 | Horizon XvuDQK · Traditional | 08/07/2009SE |
| K083063 | Bis Interface for Vitalogik Patient MonitorsOLW · Traditional | 12/16/2008SE |
| K081484 | Horizon XvuDQK · Special | 06/20/2008SE |
| K073140 | Vitalogik Model 4000/4500DSI · Special | 11/21/2007SE |
| K071899 | Bis Module for Envoy Patient MonitorOLW · Traditional | 10/22/2007SE |
| K071348 | Ems-Xl Cardiac Electrophysiology SystemDQK · Traditional | 09/07/2007SE |
Questions and answers
When was Modification to Envoy Patient Monitor cleared by the FDA?
Modification to Envoy Patient Monitor (K011784) received a 510(k) decision of Substantially Equivalent on August 16, 2001, 69 days after the submission was received.
What is the product code of K011784?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.