IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V

Warmer, Thermal, Infusion Fluid

ENTHERMICS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Enthermics Medical Systems, Inc. with the FDA for Ivnow Modular Fluid Warmer, 120v, Model Ivnow-1, Ivnow-2, Ivnow-3, Ivnow-6, Ivnow Modular Fluid Warmer 230v.

Pre-market Notification Details

• Device ID: K091336
• 510k Number: K091336
• Device Name: IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V
• Classification: Warmer, Thermal, Infusion Fluid
• Applicant: ENTHERMICS MEDICAL SYSTEMS, INC. 1601 K STREET NW Washington, DC 20006
• Contact: Emalee G Murphy
• Correspondent: Emalee G Murphy; ENTHERMICS MEDICAL SYSTEMS, INC. 1601 K STREET NW Washington, DC 20006
• Product Code: LGZ
• CFR Regulation Number: 880.5725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-05-06
• Decision Date: 2010-05-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00851962007008	K091336	000
00851962007572	K091336	000