CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG— 510(k) K802065
Substantially EquivalentPortex, Inc.
FDA 510(k) clearance K802065 for CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG, Substantially Equivalent on 1980-09-09. Applicant: Portex, Inc.. Device class: 2.
Clearance details
- Applicant
- Portex, Inc.
- Product code
- Code BSO
- Device class
- Class 2
- Regulation
- 21 CFR 868.5120
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code BSO
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Adverse events under product code BSO
product code BSO- Malfunction
- 688
- Total
- 688
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.