FDA 510(k) Premarket Notification K083336: LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL

Submission Details & Decision

Normalized public record details for 510(k) notification K083336.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K083336

Applicant / Sponsor

Smiths Medical Asd, Inc.

Device Name

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

Product Code

DWJ

Decision Date

2009-06-03

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2008-11-12

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