POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID— 510(k) K011472
Substantially EquivalentMedtronic Functional Diagnostics A/S
FDA 510(k) clearance K011472 for POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID, Substantially Equivalent on 2001-08-10. Applicant: Medtronic Functional Diagnostics A/S.
Clearance details
- Applicant
- Medtronic Functional Diagnostics A/S
- Product code
- Code FFX
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Skovlunde, DK
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.