LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm

Q: What is the product code of K150898?

The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.

FDA 510(k) K150898 · Moller Medical GmbH

Substantially Equivalent

510(k) numberK150898

Submission

Device name: LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm
Applicant: Moller Medical GmbH
Fulda, DE
Received: April 2, 2015
Decision date: December 18, 2015
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JXG – Shunt, Central Nervous System And Components
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5550
Specialty: Neurology
Implant: Yes

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Questions and answers

When was LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm cleared by the FDA?

LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm (K150898) received a 510(k) decision of Substantially Equivalent on December 18, 2015, 260 days after the submission was received.

What is the product code of K150898?

The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.