RESCAN

Ventilator, Non-continuous (respirator)

RESMED LTD.

The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Rescan.

Pre-market Notification Details

• Device ID: K034033
• 510k Number: K034033
• Device Name: RESCAN
• Classification: Ventilator, Non-continuous (respirator)
• Applicant: RESMED LTD. 14040 DANIELSON ST. Poway, CA 92064 -6857
• Contact: David D'cruz
• Correspondent: David D'cruz; RESMED LTD. 14040 DANIELSON ST. Poway, CA 92064 -6857
• Product Code: BZD
• CFR Regulation Number: 868.5905 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-12-29
• Decision Date: 2004-05-05
• Summary: summary