LEADWIRE

Cable, Transducer And Electrode, Patient, (including Connector)

SENTRY MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Sentry Medical Products, Inc. with the FDA for Leadwire.

Pre-market Notification Details

• Device ID: K933603
• 510k Number: K933603
• Device Name: LEADWIRE
• Classification: Cable, Transducer And Electrode, Patient, (including Connector)
• Applicant: SENTRY MEDICAL PRODUCTS, INC. 17171 MURPHY AVE. Irvine, CA 92614 -5915
• Contact: William E Blair
• Correspondent: William E Blair; SENTRY MEDICAL PRODUCTS, INC. 17171 MURPHY AVE. Irvine, CA 92614 -5915
• Product Code: DSA
• CFR Regulation Number: 870.2900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-07-27
• Decision Date: 1994-01-18