Bitestrip
FDA 510(k) K030869 · S.L.P. , Ltd.
510(k) numberK030869
Submission
- Device name
- Bitestrip
- Applicant
- S.L.P. , Ltd.
Tel-Aviv, IL - Received
- March 19, 2003
- Decision date
- May 14, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
| K992694 | Modification to K6-I Diagnostic System, Model K6-IKZM · Special | Myotronics-Noromed, Inc. | 09/10/1999SE |
| 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 |
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Questions and answers
When was Bitestrip cleared by the FDA?
Bitestrip (K030869) received a 510(k) decision of Substantially Equivalent on May 14, 2004, 422 days after the submission was received.
What is the product code of K030869?
The FDA product code is KZM – Device, Muscle Monitoring, a Class II (moderate risk) device regulated under 21 CFR 890.1375.