EMG MODEL SUA01 SUCTION UNIT— 510(k) K042349
Substantially EquivalentEmg Technology Co., Ltd.
FDA 510(k) clearance K042349 for EMG MODEL SUA01 SUCTION UNIT, Substantially Equivalent on 2004-12-16. Applicant: Emg Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Emg Technology Co., Ltd.
- Product code
- Code JCX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Baltimore, MD, US
Recent devices under product code JCX
view allMore clearances from Emg Technology Co., Ltd.
view allAdverse events under product code JCX
product code JCX- Death
- 11
- Malfunction
- 838
- Other
- 1
- Total
- 850
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 →
Recalls naming K042349
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042349.
Data sourced from openFDA. This site is unofficial and independent of the FDA.