Luna® G3 BPAP 25A

Ventilator, Non-continuous (respirator)

3B Medical, Inc.

The following data is part of a premarket notification filed by 3b Medical, Inc. with the FDA for Luna® G3 Bpap 25a.

Pre-market Notification Details

• Device ID: K201620
• 510k Number: K201620
• Device Name: Luna® G3 BPAP 25A
• Classification: Ventilator, Non-continuous (respirator)
• Applicant: 3B Medical, Inc. 203 Avenue A NW, Suite 300 Winter Haven, FL 33881
• Contact: Yasser Estafanous
• Correspondent: Yasser Estafanous; 3B Medical, Inc. 203 Avenue A NW, Suite 300 Winter Haven, FL 33881
• Product Code: BZD
• CFR Regulation Number: 868.5905 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-06-15
• Decision Date: 2021-01-29