Question 1

Who is the manufacturer of ALVEO-DIFFUSION TEST?

Accepted Answer

Erich Jaeger, Inc. filed the 510(k) submission for ALVEO-DIFFUSION TEST (K853443).

Question 2

What is the FDA product code for ALVEO-DIFFUSION TEST?

Accepted Answer

BZC. It is classified under 21 CFR 868.1880 as a Class 2 device in the Anesthesiology panel.

Question 3

When was ALVEO-DIFFUSION TEST cleared by the FDA?

Accepted Answer

Feb 21, 1986 (decision: SESE).

Question 4

What is the regulatory pathway for ALVEO-DIFFUSION TEST?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ALVEO-DIFFUSION TEST?

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	K853443
Device Name	ALVEO-DIFFUSION TEST
Applicant	Erich Jaeger, Inc.
Product Code	BZC · Anesthesiology
Decision Date	Feb 21, 1986
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1880
Device Class	Class 2

ALVEO-DIFFUSION TEST

Device Facts

Regulatory Classification

Identification