MSB TENS Electrodes (Disposable)
FDA 510(k) K980229 · Msb , Ltd.
510(k) numberK980229
Submission
- Device name
- MSB TENS Electrodes (Disposable)
- Applicant
- Msb , Ltd.
Marlborough, Wiltshire, GB - Received
- January 22, 1998
- Decision date
- February 27, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was MSB TENS Electrodes (Disposable) cleared by the FDA?
MSB TENS Electrodes (Disposable) (K980229) received a 510(k) decision of Substantially Equivalent on February 27, 1998, 36 days after the submission was received.
What is the product code of K980229?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.