Patient Cables and Leadwires , Disposable ECG Leadwires— 510(k) K182327
Substantially EquivalentOrantech, Inc.
FDA 510(k) clearance K182327 for Patient Cables and Leadwires , Disposable ECG Leadwires, Substantially Equivalent on 2019-01-30. Applicant: Orantech, Inc.. Device class: 2.
Clearance details
- Applicant
- Orantech, Inc.
- Product code
- Code DSA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
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More clearances from Orantech, Inc.
view allAdverse events under product code DSA
product code DSA- Death
- 2
- Total
- 2
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.