Modification to K6-I Diagnostic System, Model K6-I
FDA 510(k) K992694 · Myotronics-Noromed, Inc.
510(k) numberK992694
Submission
- Device name
- Modification to K6-I Diagnostic System, Model K6-I
- Applicant
- Myotronics-Noromed, Inc.
Tukwila, WA, US - Received
- August 12, 1999
- Decision date
- September 10, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KZM – Device, Muscle Monitoring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1375
- Specialty
- Physical Medicine
Other 510(k)s with product code KZM
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|---|---|---|---|
| K161716 | Teethan 2.0KZM · Traditional | Bts S.P.A. | 12/21/2016SE |
| K130158 | M-ScanKZM · Traditional | Bio-Research Associates, Inc. | 07/25/2013SE |
| K113677 | Grindcare MeasureKZM · Traditional | Medotech A/S | 04/05/2012SE |
| K082927 | Bioemg IIIKZM · Traditional | Bio-Research Associates, Inc. | 02/06/2009SE |
| K043373 | Dolotens Dental TM 1KZM · Abbreviated | Neuromuscular Technologies, Inc. | 09/02/2005SE |
| K030869 | BitestripKZM · Traditional | S.L.P. , Ltd. | 05/14/2004SE |
| K003176 | Bioemg II and BiojvaKZM · Traditional | Bio-Research Associates, Inc. | 01/04/2001SE |
| K003287 | Model K7 Evaluation DeviceKZM · Special | Myotronics-Noromed, Inc. | 11/06/2000SE |
| K981563 | Biopak Measurement SystemKZM · Traditional | Bio-Research Associates, Inc. | 09/15/1998SE |
| K944134 | K6-1 Diagnostic System Version 3.1KZM · Traditional | Myo-Tronics, Inc. | 12/09/1994SE |
More from Myo-Tronics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K111687 | Emg SystemHCC · Special | 09/29/2011SE |
| K040400 | Myo-Trode SG Disposable ElectrodeNUW · Traditional | 07/20/2004SE |
| K031998 | Model J-5 Mvo-MonitorNUW · Special | 07/24/2003SE |
| K013399 | Model MES-9000/EMG SystemHCC · Special | 11/13/2001SE |
| K003287 | Model K7 Evaluation DeviceKZM · Special | 11/06/2000SE |
| K992439 | Norodyn 8000 Semg System, ND-8000HCC · Special | 08/13/1999SE |
Questions and answers
When was Modification to K6-I Diagnostic System, Model K6-I cleared by the FDA?
Modification to K6-I Diagnostic System, Model K6-I (K992694) received a 510(k) decision of Substantially Equivalent on September 10, 1999, 29 days after the submission was received.
What is the product code of K992694?
The FDA product code is KZM – Device, Muscle Monitoring, a Class II (moderate risk) device regulated under 21 CFR 890.1375.