COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT— 510(k) K884235
Substantially EquivalentBurron Medical, Inc.
FDA 510(k) clearance K884235 for COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT, Substantially Equivalent on 1990-03-06. Applicant: Burron Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Burron Medical, Inc.
- 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
- Bethlehem, PA, US
Recent devices under product code DRS
view all- K254074 — TruPress
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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 Burron Medical, Inc.
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.