Question 1

Who is the manufacturer of TRANSFER CONTAINER HUMIDIFIER?

Accepted Answer

Newport Biosystems, Inc. filed the 510(k) submission for TRANSFER CONTAINER HUMIDIFIER (K881648).

Question 2

What is the FDA product code for TRANSFER CONTAINER HUMIDIFIER?

Accepted Answer

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

Question 3

When was TRANSFER CONTAINER HUMIDIFIER cleared by the FDA?

Accepted Answer

Dec 30, 1988 (decision: SESE).

Question 4

What is the regulatory pathway for TRANSFER CONTAINER HUMIDIFIER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like TRANSFER CONTAINER HUMIDIFIER?

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	K881648
Device Name	TRANSFER CONTAINER HUMIDIFIER
Applicant	Newport Biosystems, Inc.
Product Code	CAF · Anesthesiology
Decision Date	Dec 30, 1988
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5630
Device Class	Class 2

TRANSFER CONTAINER HUMIDIFIER

Device Facts

Regulatory Classification

Identification