Motility Probe Model Numbers P31 Thru P38, P40 Thru P43 and P50

FDA 510(k) K980980 · Konigsberg Instruments, Inc.

Substantially Equivalent

510(k) numberK980980

Submission

Device name
Motility Probe Model Numbers P31 Thru P38, P40 Thru P43 and P50
Applicant
Konigsberg Instruments, Inc.
Pasadena, CA, US
Received
March 17, 1998
Decision date
June 15, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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Questions and answers

When was Motility Probe Model Numbers P31 Thru P38, P40 Thru P43 and P50 cleared by the FDA?

Motility Probe Model Numbers P31 Thru P38, P40 Thru P43 and P50 (K980980) received a 510(k) decision of Substantially Equivalent on June 15, 1998, 90 days after the submission was received.

What is the product code of K980980?

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