PARKONE

Device, Analysis, Anterior Segment

OCULUS OPTIKGERATE GMBH

The following data is part of a premarket notification filed by Oculus Optikgerate Gmbh with the FDA for Parkone.

Pre-market Notification Details

• Device ID: K073508
• 510k Number: K073508
• Device Name: PARKONE
• Classification: Device, Analysis, Anterior Segment
• Applicant: OCULUS OPTIKGERATE GMBH MUNCHHOLZHAUSER STR. 29 Wetzlar, DE D-35582
• Contact: Joerg Iwanczuk
• Correspondent: Joerg Iwanczuk; OCULUS OPTIKGERATE GMBH MUNCHHOLZHAUSER STR. 29 Wetzlar, DE D-35582
• Product Code: MXK
• Subsequent Product Code: HKO
• Subsequent Product Code: HLQ
• CFR Regulation Number: 886.1850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-12-13
• Decision Date: 2008-09-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04049584000217	K073508	000