OXYMAX

Computer, Oxygen-uptake

COLUMBUS INSTRUMENTS INTL. CORP.

The following data is part of a premarket notification filed by Columbus Instruments Intl. Corp. with the FDA for Oxymax.

Pre-market Notification Details

• Device ID: K895791
• 510k Number: K895791
• Device Name: OXYMAX
• Classification: Computer, Oxygen-uptake
• Applicant: COLUMBUS INSTRUMENTS INTL. CORP. P.O. BOX 44049 Columbus, OH 43204
• Contact: Jan Czekajewski
• Correspondent: Jan Czekajewski; COLUMBUS INSTRUMENTS INTL. CORP. P.O. BOX 44049 Columbus, OH 43204
• Product Code: BZL
• CFR Regulation Number: 868.1730 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-09-28
• Decision Date: 1990-03-28