FOCUS

Unit, X-ray, Extraoral With Timer

INSTRUMENTARIUM CORP.

The following data is part of a premarket notification filed by Instrumentarium Corp. with the FDA for Focus.

Pre-market Notification Details

• Device ID: K001729
• 510k Number: K001729
• Device Name: FOCUS
• Classification: Unit, X-ray, Extraoral With Timer
• Applicant: INSTRUMENTARIUM CORP. 300 WEST EDGERTON AVE. Milwaukee, WI 53207
• Contact: Doug Woods
• Correspondent: Doug Woods; INSTRUMENTARIUM CORP. 300 WEST EDGERTON AVE. Milwaukee, WI 53207
• Product Code: EHD
• CFR Regulation Number: 872.1800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-06-07
• Decision Date: 2000-07-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06430035872695	K001729	000
06430035872459	K001729	000