ENTERALITE

Pump, Infusion, Enteral

ZEVEX INTL., INC.

The following data is part of a premarket notification filed by Zevex Intl., Inc. with the FDA for Enteralite.

Pre-market Notification Details

• Device ID: K954735
• 510k Number: K954735
• Device Name: ENTERALITE
• Classification: Pump, Infusion, Enteral
• Applicant: ZEVEX INTL., INC. P.O. BOX 414 West Jordan, UT 80404 -0414
• Contact: Dan Reigle
• Correspondent: Dan Reigle; ZEVEX INTL., INC. P.O. BOX 414 West Jordan, UT 80404 -0414
• Product Code: LZH
• CFR Regulation Number: 880.5725 [🔎]
• Decision: Se Subject To Tracking Reg (ST)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-10-16
• Decision Date: 1996-04-15
• Summary: summary