DISPOSABLE PRESSURE TRANSDUCER— 510(k) K091408
Substantially EquivalentShenzhen Ant Hi-Tech Industrial Co., Ltd.
FDA 510(k) clearance K091408 for DISPOSABLE PRESSURE TRANSDUCER, Substantially Equivalent on 2009-08-18. Applicant: Shenzhen Ant Hi-Tech Industrial Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Ant Hi-Tech Industrial Co., Ltd.
- Product code
- Code DRS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2850
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Recent devices under product code DRS
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- K221782 — Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
- K172458 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
- K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
More clearances from Shenzhen Ant Hi-Tech Industrial Co., Ltd.
view allAdverse events under product code DRS
product code DRS- Death
- 8
- Malfunction
- 776
- Total
- 784
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.