BIOTEMP

Warmer, Thermal, Infusion Fluid

MEDADVANCES, INC.

The following data is part of a premarket notification filed by Medadvances, Inc. with the FDA for Biotemp.

Pre-market Notification Details

• Device ID: K896018
• 510k Number: K896018
• Device Name: BIOTEMP
• Classification: Warmer, Thermal, Infusion Fluid
• Applicant: MEDADVANCES, INC. 3414 22ND. ST. Lubbock, TX 79410
• Contact: Patrick Griffin
• Correspondent: Patrick Griffin; MEDADVANCES, INC. 3414 22ND. ST. Lubbock, TX 79410
• Product Code: LGZ
• CFR Regulation Number: 880.5725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-10-16
• Decision Date: 1990-02-09