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: K140054
• 510k Number: K140054
• Device Name: RESCAN
• Classification: Ventilator, Non-continuous (respirator)
• Applicant: RESMED LTD 9001 SPECTRUM CENTER BOULEVARD San Diego, CA 92123
• Contact: Jim Cassi
• Correspondent: Jim Cassi; RESMED LTD 9001 SPECTRUM CENTER BOULEVARD San Diego, CA 92123
• Product Code: BZD
• Subsequent Product Code: CBK
• Subsequent Product Code: MNS
• Subsequent Product Code: MNT
• CFR Regulation Number: 868.5905 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-01-09
• Decision Date: 2014-05-16
• Summary: summary