FDA 510(k) Premarket Notification K020219: RPI SKIN OR AIR TEMPERATURE PROBE

Submission Details & Decision

Normalized public record details for 510(k) notification K020219.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K020219

Applicant / Sponsor

Replacement Parts Industries, Inc.

Device Name

RPI SKIN OR AIR TEMPERATURE PROBE

Product Code

FMT

Decision Date

2002-04-12

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

General Hospital (HO)

Clearance Type

Traditional

Third Party Flag

Date Received

2002-01-22

Related Establishments / Registrations

VINCENT MEDICAL MANUFACTURING. CO., LTD. Registration: 1000604079 View Registration
REPLACEMENT PARTS INDUSTRIES, INC. Registration: 1000617661 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1034876 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration
DeRoyal Industries, Inc. Registration: 1054241 View Registration
TOYO MEDICAL CO. Registration: 1054713 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1055236 View Registration
RG Medical USA Registration: 1057358 View Registration
TARRY MEDICAL PRODUCTS, INC. Registration: 1226711 View Registration
SunMed Group Holdings, LLC Registration: 1314417 View Registration
Graphic Controls Acquisition Corp.dba Nissha Medical Technologies Registration: 1317188 View Registration
INTERNATIONAL BIOMEDICAL, LTD. Registration: 1625392 View Registration
BIOSEAL Registration: 2027062 View Registration
FISHER & PAYKEL HEALTHCARE, INC. Registration: 2085602 View Registration
DRAEGER MEDICAL SYSTEMS, INC. Registration: 2510954 View Registration
DRAEGERWERK AG & CO. KGAA Registration: 3001104093 View Registration
VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO., LTD. Registration: 3004050971 View Registration
ATOM MEDICAL CORPORATION Registration: 3005652389 View Registration
Thermometrics Mexico, S.A. de C.V Registration: 3005934741 View Registration
WIPRO GE HEALTHCARE PRIVATE Ltd. Registration: 3007734888 View Registration
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. Registration: 3008729547 View Registration
AirLife Finland Oy Registration: 3010838917 View Registration
Integrated Cable Assembly Holdings Sa De Cv Registration: 3012086037 View Registration
Amphenol (Changzhou) Connector Systems Co., Ltd. Registration: 3012348048 View Registration
Datex-Ohmeda, Inc. Registration: 3014220748 View Registration
CAF MEDICAL SOLUTIONS INC Registration: 3021559257 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
Datex-Ohmeda, Inc. Registration: 3036470679 View Registration
FISHER & PAYKEL HEALTHCARE, LTD. Registration: 9611451 View Registration
Draegerwerk AG & Co. KGaA Registration: 9611500 View Registration
DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. Registration: 9613793 View Registration
Wipro GE Healthcare Private Ltd. Registration: 9617277 View Registration
GE MEDICAL SYSTEMS (CHINA) CO., LTD. Registration: 9710602 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.