Ultipor U55/U55N Breathing Circuit Filter And Heat And Moisture Exchanger

Filter, Bacterial, Breathing-circuit

Pall Corporation

The following data is part of a premarket notification filed by Pall Corporation with the FDA for Ultipor U55/u55n Breathing Circuit Filter And Heat And Moisture Exchanger.

Pre-market Notification Details

• Device ID: K211286
• 510k Number: K211286
• Device Name: Ultipor U55/U55N Breathing Circuit Filter And Heat And Moisture Exchanger
• Classification: Filter, Bacterial, Breathing-circuit
• Applicant: Pall Corporation 25 Harbor Park Drive Port Washington, NY 11050
• Contact: Brian Goetz
• Correspondent: Randy Prebula; Hogan Lovells U.S. LLP 555 Thirteenth Street NW Washington, DC 20004
• Product Code: CAH
• CFR Regulation Number: 868.5260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-04-27
• Decision Date: 2021-11-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15034480315868	K211286	000
00860007036101	K211286	000