IMPERIUM

System, Environmental Control, Powered

TELEDYNE BROWN ENGINEERING

The following data is part of a premarket notification filed by Teledyne Brown Engineering with the FDA for Imperium.

Pre-market Notification Details

• Device ID: K953905
• 510k Number: K953905
• Device Name: IMPERIUM
• Classification: System, Environmental Control, Powered
• Applicant: TELEDYNE BROWN ENGINEERING CUMMINGS RESEARCH PARK 300 SPARKMAN DR. Huntsville, AL 35807
• Contact: D. K Martin
• Correspondent: D. K Martin; TELEDYNE BROWN ENGINEERING CUMMINGS RESEARCH PARK 300 SPARKMAN DR. Huntsville, AL 35807
• Product Code: IQA
• CFR Regulation Number: 890.3725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-08-18
• Decision Date: 1995-11-21