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

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 ID	BK020043
510k Number	BK020043
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
Classification	Warmer, Blood, Non-electromagnetic Radiation
Applicant	Level 1 Technologies, Inc. 160 Weymouth Street Rockland, MA 02370
Product Code	BSB
CFR Regulation Number	864.9205 [🔎]
Decision	Substantially Equivalent (SE)
Type	510(k) Traditio
3rd Party Reviewed	No
Combination Product	No
Date Received	2002-10-11
Decision Date	2003-06-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50695085829506	BK020043	000
50695085829261	BK020043	000
50695085002930	BK020043	000
50695085001872	BK020043	000
50695085804008	BK020043	000