VITAL PAK

Computer, Diagnostic, Pre-programmed, Single-function

VITAL SIGNS, INC.

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

Pre-market Notification Details

• Device ID: K955417
• 510k Number: K955417
• Device Name: VITAL PAK
• Classification: Computer, Diagnostic, Pre-programmed, Single-function
• Applicant: VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512
• Contact: Whitney G Torning
• Correspondent: Whitney G Torning; VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512
• Product Code: DXG
• CFR Regulation Number: 870.1435 [🔎]
• Decision: Substantially Equivalent - Kit (SESK)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-11-27
• Decision Date: 1996-03-08
• Summary: summary