UNIHEART

Nebulizer (direct Patient Interface)

VORTRAN MEDICAL TECHNOLOGY 1, INC.

The following data is part of a premarket notification filed by Vortran Medical Technology 1, Inc. with the FDA for Uniheart.

Pre-market Notification Details

• Device ID: K943600
• 510k Number: K943600
• Device Name: UNIHEART
• Classification: Nebulizer (direct Patient Interface)
• Applicant: VORTRAN MEDICAL TECHNOLOGY 1, INC. 3941 J ST., SUITE 354 Sacramento, CA 95819
• Contact: Gorson A Wong
• Correspondent: Gorson A Wong; VORTRAN MEDICAL TECHNOLOGY 1, INC. 3941 J ST., SUITE 354 Sacramento, CA 95819
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-07-25
• Decision Date: 1994-10-13