TASMAN

Ventilator, Non-continuous (respirator)

RESMED LTD.

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

Pre-market Notification Details

• Device ID: K112393
• 510k Number: K112393
• Device Name: TASMAN
• Classification: Ventilator, Non-continuous (respirator)
• Applicant: RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego, CA 92123
• Contact: David D'cruz
• Correspondent: David D'cruz; RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego, CA 92123
• Product Code: BZD
• CFR Regulation Number: 868.5905 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-08-19
• Decision Date: 2011-11-16
• Summary: summary