Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111

FDA 510(k) K981733 · Medtronic Functional Diagnostics A/S

Substantially Equivalent

510(k) numberK981733

Submission

Device name
Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111
Applicant
Medtronic Functional Diagnostics A/S
Skovlunde, DK
Received
May 18, 1998
Decision date
February 4, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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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More from Crospon, Ltd.

510(k)DeviceDecision
K014269Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf Id…MYE · Traditional 11/21/2002SE
K011471Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber ProberFFX · Traditional 11/08/2002SE
K002992Disposable Hypodermic Needle Electrode, Model 9013S0421,9013S0431,9013S0441,9013S0451,901…IKT · Traditional 08/15/2001SE
K011472Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry…FFX · Traditional 08/10/2001SE
K010130Polygram 98 Esophageal Manometry Testing Application, Model 9043S0103FFX · Special 02/07/2001SE
K000386Polygram 98 Anorectal Function Testing Application, Model 9043S0111FFX · Traditional 05/05/2000SE
K992715Neuro Urodynamic Suite, Model 9032E0101FEN · Traditional 02/28/2000SE
K992713Polygraf Id, Polygram '98 Esophageal Manometry Testing Application, Models…FFX · Traditional 11/10/1999SE
K991389Anorectal Manometry Suite, Model 9032S0201FFX · Traditional 07/15/1999SE
K990375Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75IKT · Special 03/09/1999SE

Questions and answers

When was Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111 cleared by the FDA?

Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111 (K981733) received a 510(k) decision of Substantially Equivalent on February 4, 1999, 262 days after the submission was received.

What is the product code of K981733?

The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.