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Warmer, Blood, Non-electromagnetic Radiation

Level 1 Technologies, Inc.

The following data is part of a premarket notification filed by Level 1 Technologies, Inc. with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

Device IDBK020043
510k NumberBK020043
Device Name:510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
ClassificationWarmer, Blood, Non-electromagnetic Radiation
Applicant Level 1 Technologies, Inc. 160 Weymouth Street Rockland,  MA  02370
Product CodeBSB  
CFR Regulation Number864.9205 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-11
Decision Date2003-06-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50695085829506 BK020043 000
50695085829261 BK020043 000
50695085002930 BK020043 000
50695085001872 BK020043 000
50695085804008 BK020043 000

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