COMBITRANS MONITORING SETS AND ACCESSORIES— 510(k) K102033
Substantially EquivalentB.Braun Melsungen AG
FDA 510(k) clearance K102033 for COMBITRANS MONITORING SETS AND ACCESSORIES, Substantially Equivalent on 2011-04-07. Applicant: B.Braun Melsungen AG. Device class: 2.
Clearance details
- Applicant
- B.Braun Melsungen AG
- 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
- Abbreviated
- Location
- Allentown, PA, 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 B.Braun Melsungen AG
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.