WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM

Blood Pressure Cuff

WELCH ALLYN, INC.

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

Pre-market Notification Details

• Device ID: K012455
• 510k Number: K012455
• Device Name: WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
• Classification: Blood Pressure Cuff
• Applicant: WELCH ALLYN, INC. 95 OLD SHOALS RD. Arden, NC 28704
• Contact: David A Young
• Correspondent: David A Young; WELCH ALLYN, INC. 95 OLD SHOALS RD. Arden, NC 28704
• Product Code: DXQ
• CFR Regulation Number: 870.1120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-08-01
• Decision Date: 2001-08-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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