HOT SHOT FLUID WARMER IV FLUIDS

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la

INFRA-MED TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Infra-med Technologies, Inc. with the FDA for Hot Shot Fluid Warmer Iv Fluids.

Pre-market Notification Details

• Device ID: K992258
• 510k Number: K992258
• Device Name: HOT SHOT FLUID WARMER IV FLUIDS
• Classification: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
• Applicant: INFRA-MED TECHNOLOGIES, INC. 3535 FIREWHEEL DRIVE, SUITE A Flower Mound, TX 75028 -2628
• Contact: Bertram J Hudson
• Correspondent: Bertram J Hudson; INFRA-MED TECHNOLOGIES, INC. 3535 FIREWHEEL DRIVE, SUITE A Flower Mound, TX 75028 -2628
• Product Code: LDQ
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-07-06
• Decision Date: 2000-01-12