Stimuplex HNS-12, Model 4892098

FDA 510(k) K052313 · Stockert GmbH

Substantially Equivalent

510(k) numberK052313

Submission

Device name
Stimuplex HNS-12, Model 4892098
Applicant
Stockert GmbH
Freiburg, B-W, DE
Received
August 25, 2005
Decision date
November 17, 2005
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BXN – Stimulator, Nerve, Battery-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 868.2775
Specialty
Anesthesiology

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More from Xavant Technology (Pty), Ltd.

510(k)DeviceDecision
K070336Stockert Neuro N50, MODEL12267GXD · Traditional 06/14/2007SE
K070134Modification to Stimuplex HNS-12, Model 4892098BXN · Special 03/22/2007SE
K061983Stimuplex PenBXN · Abbreviated 11/21/2006SE
K003983Stimuplex HNS-11BXN · Traditional 06/06/2001SE

Questions and answers

When was Stimuplex HNS-12, Model 4892098 cleared by the FDA?

Stimuplex HNS-12, Model 4892098 (K052313) received a 510(k) decision of Substantially Equivalent on November 17, 2005, 84 days after the submission was received.

What is the product code of K052313?

The FDA product code is BXN – Stimulator, Nerve, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 868.2775.