TRANTECSILICONE QUARTZ DISP. TRANSD— 510(k) K833792
Substantially EquivalentAmerican Bentley
FDA 510(k) clearance K833792 for TRANTECSILICONE QUARTZ DISP. TRANSD, Substantially Equivalent on 1984-02-10. Applicant: American Bentley. Device class: 2.
Clearance details
- Applicant
- American Bentley
- 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
- Mchenry, IL, US
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- K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
More clearances from American Bentley
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.