Question 1

Who is the manufacturer of SINGLE USE NEBULIZER, ADJUST. AIR-?

Accepted Answer

Airlife, Inc. filed the 510(k) submission for SINGLE USE NEBULIZER, ADJUST. AIR- (K830895).

Question 2

What is the FDA product code for SINGLE USE NEBULIZER, ADJUST. AIR-?

Accepted Answer

CAF. It is classified under 21 CFR 868.5630 as a Class 2 device in the Anesthesiology panel.

Question 3

When was SINGLE USE NEBULIZER, ADJUST. AIR- cleared by the FDA?

Accepted Answer

Apr 28, 1983 (decision: SESE).

Question 4

What is the regulatory pathway for SINGLE USE NEBULIZER, ADJUST. AIR-?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SINGLE USE NEBULIZER, ADJUST. AIR-?

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	K830895
Device Name	SINGLE USE NEBULIZER, ADJUST. AIR-
Applicant	Airlife, Inc.
Product Code	CAF · Anesthesiology
Decision Date	Apr 28, 1983
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5630
Device Class	Class 2

SINGLE USE NEBULIZER, ADJUST. AIR-

Device Facts

Regulatory Classification

Identification