Question 1

Who is the manufacturer of ALPHA OMEGA DUAL COOLER-HEATER?

Accepted Answer

Alpha Omega, Inc. filed the 510(k) submission for ALPHA OMEGA DUAL COOLER-HEATER (K001520).

Question 2

What is the FDA product code for ALPHA OMEGA DUAL COOLER-HEATER?

Accepted Answer

DWC. It is classified under 21 CFR 870.4250 as a Class 2 device in the Cardiovascular panel.

Question 3

When was ALPHA OMEGA DUAL COOLER-HEATER cleared by the FDA?

Accepted Answer

Nov 22, 2000 (decision: SESE).

Question 4

What is the regulatory pathway for ALPHA OMEGA DUAL COOLER-HEATER?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like ALPHA OMEGA DUAL COOLER-HEATER?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K001520
Device Name	ALPHA OMEGA DUAL COOLER-HEATER
Applicant	Alpha Omega, Inc.
Product Code	DWC · Cardiovascular
Decision Date	Nov 22, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4250
Device Class	Class 2

ALPHA OMEGA DUAL COOLER-HEATER

Device Facts

Regulatory Classification

Identification