Question 1

Who is the manufacturer of GALVA 5-T?

Accepted Answer

Zimmer Elektromedizin GmbH filed the 510(k) submission for GALVA 5-T (K960969).

Question 2

What is the FDA product code for GALVA 5-T?

Accepted Answer

GZJ. It is classified under 21 CFR 882.5890 as a Class 2 device in the Neurology panel.

Question 3

When was GALVA 5-T cleared by the FDA?

Accepted Answer

May 15, 1996 (decision: SESE).

Question 4

What is the regulatory pathway for GALVA 5-T?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like GALVA 5-T?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K960969
Device Name	GALVA 5-T
Applicant	Zimmer Elektromedizin GmbH
Product Code	GZJ · Neurology
Decision Date	May 15, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5890
Device Class	Class 2

GALVA 5-T

Device Facts

Regulatory Classification

Identification