Polygraf Id, Polygram '98 Esophageal Manometry Testing Application, Models 9043G0121-9043G0151, 9043S0101
FDA 510(k) K992713 · Medtronic Functional Diagnostics A/S
510(k) numberK992713
Submission
- Device name
- Polygraf Id, Polygram '98 Esophageal Manometry Testing Application, Models 9043G0121-9043G0151, 9043S0101
- Applicant
- Medtronic Functional Diagnostics A/S
Skovlunde, DK - Received
- August 12, 1999
- Decision date
- November 10, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFX – System, Gastrointestinal Motility (Electrical)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Specialty
- Gastroenterology, Urology
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| K183072 | EndoFLIP SystemFFX · Traditional | Crospon, Ltd. | 02/15/2019SE |
More from Crospon, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K014269 | Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf Id…MYE · Traditional | 11/21/2002SE |
| K011471 | Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber ProberFFX · Traditional | 11/08/2002SE |
| K002992 | Disposable Hypodermic Needle Electrode, Model 9013S0421,9013S0431,9013S0441,9013S0451,901…IKT · Traditional | 08/15/2001SE |
| K011472 | Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry…FFX · Traditional | 08/10/2001SE |
| K010130 | Polygram 98 Esophageal Manometry Testing Application, Model 9043S0103FFX · Special | 02/07/2001SE |
| K000386 | Polygram 98 Anorectal Function Testing Application, Model 9043S0111FFX · Traditional | 05/05/2000SE |
| K992715 | Neuro Urodynamic Suite, Model 9032E0101FEN · Traditional | 02/28/2000SE |
| K991389 | Anorectal Manometry Suite, Model 9032S0201FFX · Traditional | 07/15/1999SE |
| K990375 | Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75IKT · Special | 03/09/1999SE |
| K981733 | Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111FFX · Traditional | 02/04/1999SE |
Questions and answers
When was Polygraf Id, Polygram '98 Esophageal Manometry Testing Application, Models 9043G0121-9043G0151, 9043S0101 cleared by the FDA?
Polygraf Id, Polygram '98 Esophageal Manometry Testing Application, Models 9043G0121-9043G0151, 9043S0101 (K992713) received a 510(k) decision of Substantially Equivalent on November 10, 1999, 90 days after the submission was received.
What is the product code of K992713?
The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.