WELCH ALLYN ABPM 6100

System, Measurement, Blood-pressure, Non-invasive

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Abpm 6100.

Pre-market Notification Details

• Device ID: K021756
• 510k Number: K021756
• Device Name: WELCH ALLYN ABPM 6100
• Classification: System, Measurement, Blood-pressure, Non-invasive
• 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: DXN
• CFR Regulation Number: 870.1130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-05-29
• Decision Date: 2002-06-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00732094070453	K021756	000
00732094070446	K021756	000
00732094070439	K021756	000
00732094070422	K021756	000