STEALTHSHIELD

Electrode, Electrocardiograph

VITAL CONNECTIONS, INC.

The following data is part of a premarket notification filed by Vital Connections, Inc. with the FDA for Stealthshield.

Pre-market Notification Details

• Device ID: K970755
• 510k Number: K970755
• Device Name: STEALTHSHIELD
• Classification: Electrode, Electrocardiograph
• Applicant: VITAL CONNECTIONS, INC. 955 NORTH THIRD ST. Tipp City, OH 45371
• Contact: Mark L Meister
• Correspondent: Mark L Meister; VITAL CONNECTIONS, INC. 955 NORTH THIRD ST. Tipp City, OH 45371
• Product Code: DRX
• CFR Regulation Number: 870.2360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-03-03
• Decision Date: 1997-04-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00816396022478	K970755	000
00816396021778	K970755	000
00816396021792	K970755	000
00816396021808	K970755	000
00816396021822	K970755	000
00816396021839	K970755	000
00816396021846	K970755	000
00816396021853	K970755	000
00816396021860	K970755	000
00816396021877	K970755	000
00816396022348	K970755	000
00816396021761	K970755	000