HYPEX

Device, Rebreathing

GLOBAL BUSINESS, INC.

The following data is part of a premarket notification filed by Global Business, Inc. with the FDA for Hypex.

Pre-market Notification Details

• Device ID: K895274
• 510k Number: K895274
• Device Name: HYPEX
• Classification: Device, Rebreathing
• Applicant: GLOBAL BUSINESS, INC. 2121 CASTLEBRIDGE RD. Midlothian, VA 23113
• Contact: Lenkey Iii
• Correspondent: Lenkey Iii; GLOBAL BUSINESS, INC. 2121 CASTLEBRIDGE RD. Midlothian, VA 23113
• Product Code: BYW
• CFR Regulation Number: 868.5675 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-08-23
• Decision Date: 1990-02-23