LENSCHEK

Instrument, Measuring, Lens, Ac-powered

LEICA, INC.

The following data is part of a premarket notification filed by Leica, Inc. with the FDA for Lenschek.

Pre-market Notification Details

• Device ID: K944022
• 510k Number: K944022
• Device Name: LENSCHEK
• Classification: Instrument, Measuring, Lens, Ac-powered
• Applicant: LEICA, INC. P.O. BOX 123 Buffalo, NY 14240 -0123
• Contact: Frank J Drexelius
• Correspondent: Frank J Drexelius; LEICA, INC. P.O. BOX 123 Buffalo, NY 14240 -0123
• Product Code: HLM
• CFR Regulation Number: 886.1425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-08-17
• Decision Date: 1994-11-17