FDA 510(k) Premarket Notification K082590: SYMPHONY METER REMOTE

Submission Details & Decision

Normalized public record details for 510(k) notification K082590.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K082590

Applicant / Sponsor

Lifescan, Inc.

Device Name

SYMPHONY METER REMOTE

Product Code

LZG

Decision Date

2008-12-17

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

General Hospital (HO)

Clearance Type

Traditional

Third Party Flag

Date Received

2008-09-08

Related Establishments / Registrations

ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
F.M. HOWELL & CO. Registration: 1313700 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
MEDTRONIC MINIMED Registration: 2032227 View Registration
Isomedix Operations Inc. Registration: 2246552 View Registration
LIFESCAN SCOTLAND LTD Registration: 3001058982 View Registration
YPSOMED AG Registration: 3002806818 View Registration
MANNKIND CORPORATION Registration: 3005340341 View Registration
Sanmina Registration: 3005627859 View Registration
Viant Medical SUZHOU EPZ Co., Ltd Registration: 3006194679 View Registration
THE JAY GROUP Registration: 3006479639 View Registration
Sterigenics Shanghai ETO Ltd. Registration: 3007007790 View Registration
Flextronics Industrial (Shenzhen) Co., Ltd. Registration: 3007710663 View Registration
CeQur Corporation Registration: 3007871880 View Registration
IntriCon Corporation VH Registration: 3007939342 View Registration
TANDEM DIABETES CARE, INC. Registration: 3007981285 View Registration
Clinico Medical Sp. z o.o. Registration: 3008810357 View Registration
STERIS Sterilization Technologies (Suzhou) Ltd Registration: 3008824097 View Registration
Synergy Health Ede BV Registration: 3009337401 View Registration
ADVANCE TECHNOLOGY LTD Registration: 3009515470 View Registration
OMNI MANUFACTURING SERVICES S. A. DE C. V. Registration: 3010047442 View Registration
PROVIDENCE ENTERPRISE LIMITED Registration: 3010162782 View Registration
AvailMed S.A.De C.V. Registration: 3010291427 View Registration
ROCHE DIABETES CARE, INC. Registration: 3011393376 View Registration
ICU Medical, Inc. Registration: 3012307300 View Registration
MAINLINE MEDICAL DENTAL SUPPLY Registration: 3012421607 View Registration
ZOLLNER ELECTRONICS COSTA RICA LIMITADA Registration: 3013636348 View Registration
Tandem Diabetes Care, INC. Registration: 3013756811 View Registration
Insulet Corporation Registration: 3014585508 View Registration
CeQur SA Registration: 3015218509 View Registration
TANDEM DIABETES CARE, INC. Registration: 3016540876 View Registration
Synergy Health Ede BV Registration: 3020976354 View Registration
MODULAR MEDICAL Registration: 3027453514 View Registration
MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS Registration: 3042027705 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
SOOIL DEVELOPMENT CO., LTD. Registration: 9616814 View Registration
ICU Medical Healthcare Manufacturing S.A. de C.V. Registration: 9617604 View Registration

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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.