POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102— 510(k) K014269
Substantially EquivalentMedtronic Functional Diagnostics A/S
FDA 510(k) clearance K014269 for POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102, Substantially Equivalent on 2002-11-21. Applicant: Medtronic Functional Diagnostics A/S. Device class: 2.
Clearance details
- Applicant
- Medtronic Functional Diagnostics A/S
- Product code
- Code MYE
- Device class
- Class 2
- Regulation
- 21 CFR 876.1735
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Skovlunde, DK
Recent devices under product code MYE
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