BREATHE EASY

Condenser, Heat And Moisture (artificial Nose)

VITAL SIGNS, INC.

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

Pre-market Notification Details

• Device ID: K914336
• 510k Number: K914336
• Device Name: BREATHE EASY
• Classification: Condenser, Heat And Moisture (artificial Nose)
• Applicant: VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512
• Contact: Dennis Irlbeck
• Correspondent: Dennis Irlbeck; VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512
• Product Code: BYD
• CFR Regulation Number: 868.5375 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-09-27
• Decision Date: 1992-03-25