RAINCOAT

Set, Tubing And Support, Ventilator (w Harness)

ARTEC ENVIRONMENTAL MONITORING DIVISION

The following data is part of a premarket notification filed by Artec Environmental Monitoring Division with the FDA for Raincoat.

Pre-market Notification Details

• Device ID: K863910
• 510k Number: K863910
• Device Name: RAINCOAT
• Classification: Set, Tubing And Support, Ventilator (w Harness)
• Applicant: ARTEC ENVIRONMENTAL MONITORING DIVISION P.O. BOX 68 Noblesville, IN 46060
• Contact: Timothy D Struthers
• Correspondent: Timothy D Struthers; ARTEC ENVIRONMENTAL MONITORING DIVISION P.O. BOX 68 Noblesville, IN 46060
• Product Code: BZO
• CFR Regulation Number: 868.5975 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-10-08
• Decision Date: 1986-10-20