IPLAN

Neurological Stereotaxic Instrument

BRAINLAB AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Iplan.

Pre-market Notification Details

• Device ID: K101627
• 510k Number: K101627
• Device Name: IPLAN
• Classification: Neurological Stereotaxic Instrument
• Applicant: BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622
• Contact: Alexander Schwiersch
• Correspondent: Alexander Schwiersch; BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622
• Product Code: HAW
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-06-09
• Decision Date: 2011-06-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056481000660	K101627	000
04056481000646	K101627	000