Model MES-9000/EMG System
FDA 510(k) K013399 · Myotronics-Noromed, Inc.
510(k) numberK013399
Submission
- Device name
- Model MES-9000/EMG System
- Applicant
- Myotronics-Noromed, Inc.
Tukwila, WA, US - Received
- October 15, 2001
- Decision date
- November 13, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K122879 | EEGER4 Model 4.3HCC · Traditional | Eeg Software, LLC | 02/06/2013SE |
| K111687 | Emg SystemHCC · Special | Myotronics-Noromed, Inc. | 09/29/2011SE |
| K092675 | GrindcareHCC · Traditional | Medotech A/S | 03/03/2010SE |
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| K031998 | Model J-5 Mvo-MonitorNUW · Special | 07/24/2003SE |
| K003287 | Model K7 Evaluation DeviceKZM · Special | 11/06/2000SE |
| K992694 | Modification to K6-I Diagnostic System, Model K6-IKZM · Special | 09/10/1999SE |
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Questions and answers
When was Model MES-9000/EMG System cleared by the FDA?
Model MES-9000/EMG System (K013399) received a 510(k) decision of Substantially Equivalent on November 13, 2001, 29 days after the submission was received.
What is the product code of K013399?
The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.