UROVIEW

Table, Cystometric, Non-electric And Accessories

OEC-DIASONICS, INC.

The following data is part of a premarket notification filed by Oec-diasonics, Inc. with the FDA for Uroview.

Pre-market Notification Details

• Device ID: K872022
• 510k Number: K872022
• Device Name: UROVIEW
• Classification: Table, Cystometric, Non-electric And Accessories
• Applicant: OEC-DIASONICS, INC. 2341 SOUTH 2300 WEST P.O. BOX 25296 Salt Lake City, UT 84119
• Contact: John W Tolhurst
• Correspondent: John W Tolhurst; OEC-DIASONICS, INC. 2341 SOUTH 2300 WEST P.O. BOX 25296 Salt Lake City, UT 84119
• Product Code: KQS
• CFR Regulation Number: 876.4890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-05-26
• Decision Date: 1987-07-16