SUNBEAM RECHARGEABLE TOOTHBRUSH MODEL # 4201— 510(k) K852279
Substantially EquivalentNorthern Electric Co. Div. of Sunbeam Corp.
FDA 510(k) clearance K852279 for SUNBEAM RECHARGEABLE TOOTHBRUSH MODEL # 4201, Substantially Equivalent on 1985-07-01. Applicant: Northern Electric Co. Div. of Sunbeam Corp.. Device class: 1.
Clearance details
- Applicant
- Northern Electric Co. Div. of Sunbeam Corp.
- Product code
- Code JEQ
- Device class
- Class 1
- Regulation
- 21 CFR 872.6865
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
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- K040416 — SONICARE ADVANCE TOOTHBRUSH, MODEL 4900
More clearances from Northern Electric Co. Div. of Sunbeam Corp.
view allAdverse events under product code JEQ
product code JEQ- Injury
- 188
- Malfunction
- 2,818
- Total
- 3,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.