MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN.— 510(k) K801138
Substantially EquivalentGics Pharmaceuticals
FDA 510(k) clearance K801138 for MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN., Substantially Equivalent on 1980-07-14. Applicant: Gics Pharmaceuticals. Device class: 2.
Clearance details
- Applicant
- Gics Pharmaceuticals
- 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 Gics Pharmaceuticals
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.