CARDIO METRICS INVASIVE PRESSURE MONIT— 510(k) K841960
Substantially EquivalentSterile Design, Inc.
FDA 510(k) clearance K841960 for CARDIO METRICS INVASIVE PRESSURE MONIT, Substantially Equivalent on 1985-11-08. Applicant: Sterile Design, Inc.. Device class: 2.
Clearance details
- Applicant
- Sterile Design, 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
- Oldsmar, FL, US
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- 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 Sterile Design, 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.