HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103

System, Thermal Regulating

AUGUSTINE BIOMEDICAL & DESIGN, LLC

The following data is part of a premarket notification filed by Augustine Biomedical & Design, Llc with the FDA for Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 And M103.

Pre-market Notification Details

• Device ID: K092807
• 510k Number: K092807
• Device Name: HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103
• Classification: System, Thermal Regulating
• Applicant: AUGUSTINE BIOMEDICAL & DESIGN, LLC 6581 CITY WEST PARKWAY Eden Prairie, MN 55344
• Contact: James Ecklein
• Correspondent: James Ecklein; AUGUSTINE BIOMEDICAL & DESIGN, LLC 6581 CITY WEST PARKWAY Eden Prairie, MN 55344
• Product Code: DWJ
• CFR Regulation Number: 870.5900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-09-11
• Decision Date: 2009-12-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00749756845854	K092807	000
00855913001985	K092807	000
30855913001979	K092807	000
00855913001527	K092807	000
00855913001510	K092807	000