SMARTFLOW

Computer, Diagnostic, Programmable

FLORENCE MEDICAL LTD.

The following data is part of a premarket notification filed by Florence Medical Ltd. with the FDA for Smartflow.

Pre-market Notification Details

• Device ID: K012947
• 510k Number: K012947
• Device Name: SMARTFLOW
• Classification: Computer, Diagnostic, Programmable
• Applicant: FLORENCE MEDICAL LTD. 117 AHUZAH ST. Ra'ananna, IL 43373
• Contact: Shoshana Friedman
• Correspondent: Shoshana Friedman; FLORENCE MEDICAL LTD. 117 AHUZAH ST. Ra'ananna, IL 43373
• Product Code: DQK
• CFR Regulation Number: 870.1425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-09-04
• Decision Date: 2001-10-02
• Summary: summary