RAIN-X

Set, Tubing And Support, Ventilator (w Harness)

NOVA-VENTRX

The following data is part of a premarket notification filed by Nova-ventrx with the FDA for Rain-x.

Pre-market Notification Details

• Device ID: K812737
• 510k Number: K812737
• Device Name: RAIN-X
• Classification: Set, Tubing And Support, Ventilator (w Harness)
• Applicant: NOVA-VENTRX 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: BZO
• CFR Regulation Number: 868.5975 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-09-29
• Decision Date: 1981-10-23