FDA 510(k) Premarket Notification K001520: ALPHA OMEGA DUAL COOLER-HEATER

Submission Details & Decision

Normalized public record details for 510(k) notification K001520.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K001520

Applicant / Sponsor

Alpha Omega, Inc.

Device Name

ALPHA OMEGA DUAL COOLER-HEATER

Product Code

DWC

Decision Date

2000-11-22

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2000-05-16

Related Establishments / Registrations

Gentherm Medical, LLC Registration: 1516825 View Registration
QUEST MEDICAL, INC. Registration: 1649914 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1720929 View Registration
GENESEE BIOMEDICAL, INC. Registration: 1723241 View Registration
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION Registration: 1828100 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
LAUDA DR. R. WOBSER GMBH & CO. KG Registration: 3001588119 View Registration
SPECTRUM MEDICAL LTD Registration: 3006073153 View Registration
CardioQuip Registration: 3007899424 View Registration
LivaNova Deutschland GmbH Registration: 9611109 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 Information may be outdated or incomplete.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.