HL168JP— 510(k) K050249
Substantially EquivalentHealth & Life Co., Ltd.
FDA 510(k) clearance K050249 for HL168JP, Substantially Equivalent on 2005-03-30. Applicant: Health & Life Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Health & Life Co., Ltd.
- Product code
- Product code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Chung Ho City, Taipei, Hsien, TW
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More clearances from Health & Life Co., Ltd.
view allAdverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
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.