U-MID PREFILLED NEBULIZER

Nebulizer (direct Patient Interface)

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for U-mid Prefilled Nebulizer.

Pre-market Notification Details

• Device ID: K760585
• 510k Number: K760585
• Device Name: U-MID PREFILLED NEBULIZER
• Classification: Nebulizer (direct Patient Interface)
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1976-09-03
• Decision Date: 1976-10-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30889483584587	K760585	000