Neva System

FDA 510(k) K980627 · Urometrics, Inc.

Substantially Equivalent

510(k) numberK980627

Submission

Device name
Neva System
Applicant
Urometrics, Inc.
St. Paul, MN, US
Received
February 18, 1998
Decision date
April 7, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LIL – Monitor, Penile Tumescence
Device class
Unclassified

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K052929Preftest Professional SuiteLIL · Traditional Limestone Technologies, Inc.04/26/2006SE
K033126Monarch 21 Penile Plethysmograph SystemLIL · Special Behavioral Technology, Inc.10/29/2003SE
K000194Digital Inflection Rigidometer (Dir)LIL · Traditional Uroan Xxi Electromedicina04/10/2000SE
K991479Viser Penile Tumescence MonitorLIL · Traditional Laborie Medical Tech Corp.07/07/1999SE
K940128CAT-400UL Penile PlethysmographLIL · Traditional Farrall Instruments, Inc.01/10/1995SE
K936115CAT-600 Penile PlethysmographLIL · Traditional Farrall Instruments, Inc.01/10/1995SE
K941781Rigiscan Plus Rigidity Assessment SystemLIL · Traditional Dacomed Corp.08/25/1994SE
K925931RT2 Rigidity and Tumescence TestLIL · Traditional Compass Medical Technologies, Inc.12/21/1992SE

More from Compass Medical Technologies, Inc.

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Questions and answers

When was Neva System cleared by the FDA?

Neva System (K980627) received a 510(k) decision of Substantially Equivalent on April 7, 1998, 48 days after the submission was received.

What is the product code of K980627?

The FDA product code is LIL – Monitor, Penile Tumescence, a Unclassified device.