IMAGE MANAGEMENT SYSTEM

Colposcope (and Colpomicroscope)

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Image Management System.

Pre-market Notification Details

• Device ID: K033870
• 510k Number: K033870
• Device Name: IMAGE MANAGEMENT SYSTEM
• Classification: Colposcope (and Colpomicroscope)
• Applicant: WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220
• Contact: David Klementowski
• Correspondent: David Klementowski; WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220
• Product Code: HEX
• CFR Regulation Number: 884.1630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-12-12
• Decision Date: 2004-03-12
• Summary: summary