SKINTACT

Electrode, Electrocardiograph

LEONHARD LANG CO.

The following data is part of a premarket notification filed by Leonhard Lang Co. with the FDA for Skintact.

Pre-market Notification Details

• Device ID: K024264
• 510k Number: K024264
• Device Name: SKINTACT
• Classification: Electrode, Electrocardiograph
• Applicant: LEONHARD LANG CO. P.O. BOX 560 Stillwater, MN 55082 -0560
• Contact: Elaine Duncan
• Correspondent: Elaine Duncan; LEONHARD LANG CO. P.O. BOX 560 Stillwater, MN 55082 -0560
• Product Code: DRX
• CFR Regulation Number: 870.2360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-12-23
• Decision Date: 2003-01-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
29005531589883	K024264	000