ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM— 510(k) K963064
Substantially EquivalentLaborie Medical Tech Corp.
FDA 510(k) clearance K963064 for ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM, Substantially Equivalent on 1997-06-05. Applicant: Laborie Medical Tech Corp..
Clearance details
- Applicant
- Laborie Medical Tech Corp.
- Product code
- Code FFX
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Williston, VT, US
Adverse events under product code FFX
product code FFX- Other
- 1
- Total
- 1
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.