ADVANCE DISPOSABLE PRESSURE TRANSDUCER— 510(k) K904601
Substantially EquivalentAdvance Medical Designs, Inc.
FDA 510(k) clearance K904601 for ADVANCE DISPOSABLE PRESSURE TRANSDUCER, Substantially Equivalent on 1990-12-17. Applicant: Advance Medical Designs, Inc.. Device class: 2.
Clearance details
- Applicant
- Advance Medical Designs, 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
- Marietta, GA, US
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 Advance Medical Designs, 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.