PREDICTOR

Computer, Diagnostic, Programmable

CORAZONIX CORP.

The following data is part of a premarket notification filed by Corazonix Corp. with the FDA for Predictor.

Pre-market Notification Details

• Device ID: K871436
• 510k Number: K871436
• Device Name: PREDICTOR
• Classification: Computer, Diagnostic, Programmable
• Applicant: CORAZONIX CORP. 7700 NORTH HUDSON, SUITE 1 Oklahoma City, OK 73116
• Contact: James H Luby
• Correspondent: James H Luby; CORAZONIX CORP. 7700 NORTH HUDSON, SUITE 1 Oklahoma City, OK 73116
• Product Code: DQK
• CFR Regulation Number: 870.1425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-04-13
• Decision Date: 1987-06-19