LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL

System, Thermal Regulating

SMITHS MEDICAL ASD, INC.

The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model Sw-2013, Level 1 Snuggle Warm Left Lateral.

Pre-market Notification Details

• Device ID: K083336
• 510k Number: K083336
• Device Name: LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL
• Classification: System, Thermal Regulating
• Applicant: SMITHS MEDICAL ASD, INC. 160 WEYMOUTH ST. Rockland, MA 02370
• Contact: Christine Lloyd
• Correspondent: Christine Lloyd; SMITHS MEDICAL ASD, INC. 160 WEYMOUTH ST. Rockland, MA 02370
• Product Code: DWJ
• CFR Regulation Number: 870.5900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-11-12
• Decision Date: 2009-06-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10695085002178	K083336	000
10695085002161	K083336	000
10695085002147	K083336	000
10695085002116	K083336	000
10695085003885	K083336	000
30695085002776	K083336	000
30695085002769	K083336	000