MICROFLOW

Nebulizer (direct Patient Interface)

MOUNTAIN MEDICAL EQUIPMENT, INC.

The following data is part of a premarket notification filed by Mountain Medical Equipment, Inc. with the FDA for Microflow.

Pre-market Notification Details

• Device ID: K924684
• 510k Number: K924684
• Device Name: MICROFLOW
• Classification: Nebulizer (direct Patient Interface)
• Applicant: MOUNTAIN MEDICAL EQUIPMENT, INC. 10488 WEST CENTENNIAL RD. Littleton, CO 80127
• Contact: John K Etter
• Correspondent: John K Etter; MOUNTAIN MEDICAL EQUIPMENT, INC. 10488 WEST CENTENNIAL RD. Littleton, CO 80127
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-09-16
• Decision Date: 1992-12-15