ULTRASTIM ELECTRODE, MODEL US4040— 510(k) K000947
Substantially EquivalentAxelgaard Mfg. Co., Ltd.
FDA 510(k) clearance K000947 for ULTRASTIM ELECTRODE, MODEL US4040, Substantially Equivalent on 2000-06-16. Applicant: Axelgaard Mfg. Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Axelgaard Mfg. Co., Ltd.
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fallbrook, CA, US
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