VERSARATE FLOW RATE CONTROLER

Set, Administration, Intravascular

EMED TECHNOLOGIES CORPORATION

The following data is part of a premarket notification filed by Emed Technologies Corporation with the FDA for Versarate Flow Rate Controler.

Pre-market Notification Details

• Device ID: K123729
• 510k Number: K123729
• Device Name: VERSARATE FLOW RATE CONTROLER
• Classification: Set, Administration, Intravascular
• Applicant: EMED TECHNOLOGIES CORPORATION 1264 Hawks Flight Ct Ste 200 El Dorado Hills, CA 95762
• Contact: Peter Kollings
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2012-12-05
• Decision Date: 2012-12-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817708020540	K123729	000
00817708020304	K123729	000