EZ-BLOCKER

Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)

EZ-BLOCKER B.V.

The following data is part of a premarket notification filed by Ez-blocker B.v. with the FDA for Ez-blocker.

Pre-market Notification Details

• Device ID: K121462
• 510k Number: K121462
• Device Name: EZ-BLOCKER
• Classification: Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
• Applicant: EZ-BLOCKER B.V. 4655 KIRKWOOD COURT Boulder, CO 80301
• Contact: Lewis Ward
• Correspondent: Lewis Ward; EZ-BLOCKER B.V. 4655 KIRKWOOD COURT Boulder, CO 80301
• Product Code: CBI
• CFR Regulation Number: 868.5740 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-05-17
• Decision Date: 2012-09-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
24026704589955	K121462	000
34026704743347	K121462	000