HI-OX

Valve, Non-rebreathing

SENSORMEDICS CORP.

The following data is part of a premarket notification filed by Sensormedics Corp. with the FDA for Hi-ox.

Pre-market Notification Details

• Device ID: K020665
• 510k Number: K020665
• Device Name: HI-OX
• Classification: Valve, Non-rebreathing
• Applicant: SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645
• Contact: Earl W Draper
• Correspondent: Earl W Draper; SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645
• Product Code: CBP
• CFR Regulation Number: 868.5870 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-03-01
• Decision Date: 2002-07-30
• Summary: summary