MEDI-TRACE TRANSDUCERS/PHYSIOLOG. MONITO— 510(k) K800705
Substantially EquivalentGraphic Controls Corp.
FDA 510(k) clearance K800705 for MEDI-TRACE TRANSDUCERS/PHYSIOLOG. MONITO, Substantially Equivalent on 1980-04-16. Applicant: Graphic Controls Corp.. Device class: 2.
Clearance details
- Applicant
- Graphic Controls Corp.
- 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 Graphic Controls Corp.
view all- K981964 — MEDI-TRACE 4103 NEONATAL ELECTRODE
- K983287 — MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
- K974730 — SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)
- K980857 — MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE
- K972970 — MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
Adverse 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.