EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY

System, Thermal Regulating

SMITH MEDICAL ASD, INC.

The following data is part of a premarket notification filed by Smith Medical Asd, Inc. with the FDA for Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket, Snuggle Warm Pediatricfull Body.

Pre-market Notification Details

• Device ID: K141686
• 510k Number: K141686
• Device Name: EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY
• Classification: System, Thermal Regulating
• Applicant: SMITH MEDICAL ASD, INC. 1265 GREY FOX ROAD St. Paul, MN 55112
• Contact: Jim Johnson
• Correspondent: Jim Johnson; SMITH MEDICAL ASD, INC. 1265 GREY FOX ROAD St. Paul, MN 55112
• Product Code: DWJ
• CFR Regulation Number: 870.5900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-06-23
• Decision Date: 2014-10-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10610586043819	K141686	000
30610586043325	K141686	000
30610586043332	K141686	000
30610586043349	K141686	000
30610586043356	K141686	000
30610586043363	K141686	000
30610586043387	K141686	000
30610586043394	K141686	000
30610586043400	K141686	000
30610586043417	K141686	000
30610586043424	K141686	000
30610586043431	K141686	000
30610586043448	K141686	000
30610586043455	K141686	000
30610586043479	K141686	000
15019517116175	K141686	000
30610586043370	K141686	000