MICROFLO

Uroflowmeter

LIFE-TECH INTL., INC.

The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Microflo.

Pre-market Notification Details

• Device ID: K904557
• 510k Number: K904557
• Device Name: MICROFLO
• Classification: Uroflowmeter
• Applicant: LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221
• Contact: Coats, Md
• Correspondent: Coats, Md; LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221
• Product Code: EXY
• CFR Regulation Number: 876.1800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-10-05
• Decision Date: 1990-12-28