SIMULATOR

Medical Computers And Software

CYGNUS OF SOUTH FLORIDA, INC.

The following data is part of a premarket notification filed by Cygnus Of South Florida, Inc. with the FDA for Simulator.

Pre-market Notification Details

• Device ID: K854265
• 510k Number: K854265
• Device Name: SIMULATOR
• Classification: Medical Computers And Software
• Applicant: CYGNUS OF SOUTH FLORIDA, INC. EMERALD HILLS PROFESSIONAL PK 4700P SHERIDAN STREET HOLLYWOOD, FL 33021
• Contact: DAVID FRIEDMAN
• Correspondent: DAVID FRIEDMAN; CYGNUS OF SOUTH FLORIDA, INC. EMERALD HILLS PROFESSIONAL PK 4700P SHERIDAN STREET HOLLYWOOD, FL 33021
• Product Code: LNX
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-10-23
• Decision Date: 1986-03-18