TRACER

Stimulator, Nerve, Battery-powered

LIFE-TECH INTL., INC.

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

Pre-market Notification Details

• Device ID: K881842
• 510k Number: K881842
• Device Name: TRACER
• Classification: Stimulator, Nerve, Battery-powered
• 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: BXN
• CFR Regulation Number: 868.2775 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-05-02
• Decision Date: 1988-08-31