AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)

Holding Chambers, Direct Patient Interface

TRUDELL MEDICAL INTL.

The following data is part of a premarket notification filed by Trudell Medical Intl. with the FDA for Aerochamber Plus Flow-vu Anti-static Valved Holding Chamber (vhc).

Pre-market Notification Details

• Device ID: K112010
• 510k Number: K112010
• Device Name: AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)
• Classification: Holding Chambers, Direct Patient Interface
• Applicant: TRUDELL MEDICAL INTL. 725 THIRD ST. London, Ontario, CA N5v 5g4
• Contact: Darryl Fischer
• Correspondent: Darryl Fischer; TRUDELL MEDICAL INTL. 725 THIRD ST. London, Ontario, CA N5v 5g4
• Product Code: NVP
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-07-14
• Decision Date: 2012-07-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50604351888109	K112010	000
00604351003903	K112010	000
00604351003910	K112010	000
00604351003927	K112010	000
00604351004788	K112010	000
00604351004801	K112010	000
00604351004825	K112010	000
00604351004832	K112010	000
00604351788015	K112010	000
50604351788102	K112010	000
00604351798014	K112010	000
50604351798101	K112010	000
50604351798507	K112010	000
00604351808010	K112010	000
50604351808107	K112010	000
00604351888012	K112010	000
00604351003897	K112010	000