FDA 510(k) Premarket Notification K171373: 3M Bair Hugger Model 675 Total Temperature Management System

Submission Details & Decision

Normalized public record details for 510(k) notification K171373.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K171373

Applicant / Sponsor

3M Company

Device Name

3M Bair Hugger Model 675 Total Temperature Management System

Product Code

DWJ

Decision Date

2017-10-10

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2017-05-10

Related Establishments / Registrations

DRE Med Registration: 1000122786 View Registration
Polimeros Formula de Tecate S.A de C.V Registration: 1000484830 View Registration
C.R. BARD, INC. Registration: 1018233 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration
STERIS CORPORATION Registration: 1043572 View Registration
ENCOMPASS GROUP, LLC. Registration: 1043644 View Registration
DeRoyal Industries, Inc. Registration: 1054241 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1055236 View Registration
ADROIT MEDICAL SYSTEMS, INC. Registration: 1055823 View Registration
DeRoyal Industries, Inc. Registration: 1060680 View Registration
INFINIUM MEDICAL, INC. Registration: 1066427 View Registration
BELMONT MEDICAL TECHNOLOGIES Registration: 1219702 View Registration
Dielectrics, Inc. Registration: 1220351 View Registration
MEDLINE INDUSTRIES, LP - Northfield Registration: 1417592 View Registration
Gentherm Medical, LLC Registration: 1516825 View Registration
Salaera, LLC d.b.a Maxtec Registration: 1722070 View Registration
MEDIVANCE, INC. Registration: 1725056 View Registration
3T Medical Systems Inc. Registration: 1836518 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
Sterigenics U.S., LLC Registration: 2029015 View Registration
Isomedix Operations Inc. Registration: 2032112 View Registration
BENCHMARK ELECTRONICS, INC. Registration: 2133641 View Registration
MINNETRONIX, INC. Registration: 2133810 View Registration
NORTECH SYSTEMS, INC. Registration: 2183613 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
DEROYAL INDUSTRIES, INC. Registration: 2320762 View Registration
NOVAMED-USA Registration: 2432320 View Registration
XODUS MEDICAL, INC. Registration: 2530138 View Registration
Covidien Registration: 2936999 View Registration
NPA de México S. de R.L. de C.V. Registration: 3003542872 View Registration
CDR Manufacturing, Inc., DBA Keytronic Registration: 3003857828 View Registration
Sino Protection (Hefei) Medical Products Co. ltd. Registration: 3004362278 View Registration
AIM B.V. Registration: 3004491421 View Registration
R.H. ELECTRONICS LTD. Registration: 3005238200 View Registration
Augustine Temperature Management, LLC Registration: 3005857264 View Registration
Sterigenics Belgium Petit Rechain S.A. Registration: 3005941719 View Registration
La Ada De Acuna, S. de. R. L. de C. V. Registration: 3005997949 View Registration
Creative Foam Corporation dba MT. OLIVE MFG Registration: 3006240053 View Registration
AccuMed Corp. Registration: 3007309299 View Registration
JIANGYIN SINBON ELECTRONICS CO LTD Registration: 3007616088 View Registration
JIANGYIN PUREMED Registration: 3008352384 View Registration
SCANFIL ATVIDABERG AB Registration: 3008727520 View Registration
J STERLING INDUSTRIES LLC Registration: 3008879776 View Registration
Hangzhou Tappa Medical Technology Co., Ltd. Registration: 3009093866 View Registration
Microtrol Sterilisation Services Pvt. Ltd. Registration: 3009609358 View Registration
Integra Biotechnical, SA de CV Registration: 3009746061 View Registration
Jiangmen Dacheng Medical Equipment Co., Ltd. Registration: 3010168054 View Registration
TRIBALCO Registration: 3010317211 View Registration
Shanghai Xodus Medical Company Limited Registration: 3010380518 View Registration
BETACERA INC. Registration: 3010476117 View Registration
ZOLL Circulation, Inc. Registration: 3010617000 View Registration
CARE ESSENTIALS PTY LTD Registration: 3011059079 View Registration
ICU Medical, Inc. Registration: 3012307300 View Registration
CARE ESSENTIALS INTERNATIONAL PVT LTD. Registration: 3012315097 View Registration
MAINLINE MEDICAL DENTAL SUPPLY Registration: 3012421607 View Registration
SANICURE BV Registration: 3012494290 View Registration
AVACORE TECHNOLOGIES, INC. Registration: 3012689738 View Registration
UPTAKE MEDICAL TECHNOLOGY INC. Registration: 3012972101 View Registration
Dymax, Corp. Registration: 3013041594 View Registration
ORTA MEDICAL LTD Registration: 3013188547 View Registration
WEAR TEX S. DE R.L. DE C.V. Registration: 3013410562 View Registration
CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
ITEK Registration: 3014263632 View Registration
O&M Halyard, Inc. Registration: 3014421917 View Registration
BRAINCOOL AB Registration: 3014426939 View Registration
TEC COM MEDIZINTECHNIK GMBH Registration: 3016507522 View Registration
AG MARKETING & DEVELOPMENT GROUP INC DBA AGMD GROUP Registration: 3016844398 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
TSC Life Registration: 3021073836 View Registration
ZOLL International Holding B.V. Registration: 3029871637 View Registration
HADLEIGH HEALTH TECHNOLOGIES Registration: 3030597679 View Registration
Solventum US LLC Registration: 3031841433 View Registration
Solventum Germany GmbH Registration: 3032911850 View Registration
Geelong Healthcare Manufacturing Pvt Ltd Registration: 3034393266 View Registration
HUMANITY LIFE EXTENSION, LLC Registration: 3035108304 View Registration
Solventum US LLC Registration: 3036108847 View Registration
The Surgical Company International B.V. Registration: 3038241934 View Registration
SOLVENTUM US LLC (Apodaca) Registration: 3041276890 View Registration
SOLVENTUM US LLC Registration: 3042272797 View Registration
ZAPALIGN LLC Registration: 3043226252 View Registration
DSV CONTRACT LOGISTICS Registration: 3044156918 View Registration
CAREMED SUPPLY, INC. Registration: 8022590 View Registration
Covidien Registration: 9610849 View Registration
PRODUCTOS PARA EL CUIDADO DE LA SALUD Registration: 9611590 View Registration
COPIOUS INTL., INC. Registration: 9614306 View Registration
La Ada de Acuna Registration: 9616096 View Registration
ICU Medical Healthcare Manufacturing S.A. de C.V. Registration: 9616567 View Registration
STIHLER ELECTRONIC GMBH Registration: 9617473 View Registration
ICU Medical Healthcare Manufacturing S.A. de C.V. Registration: 9617604 View Registration
3M EDUMEX, S.A DE C.V Registration: 9680284 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.