G.HLAMP

Amplifier, Physiological Signal

G.TEC MEDICAL ENGINEERING GMBH

The following data is part of a premarket notification filed by G.tec Medical Engineering Gmbh with the FDA for G.hlamp.

Pre-market Notification Details

• Device ID: K123255
• 510k Number: K123255
• Device Name: G.HLAMP
• Classification: Amplifier, Physiological Signal
• Applicant: G.TEC MEDICAL ENGINEERING GMBH SIERNINGSTRASSE 14 Schiedlberg, AT 4521
• Contact: Christoph Guger
• Product Code: GWL
• CFR Regulation Number: 882.1835 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2012-10-18
• Decision Date: 2012-12-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
EBCI7092US0	K123255	000
EBCI7091US0	K123255	000
EBCI7003US0	K123255	000
EBCI70030	K123255	000
EBCI7002US0	K123255	000
EBCI70020	K123255	000
EBCI7001US0	K123255	000
EBCI70010	K123255	000