Question 1

Who is the manufacturer of NEUMOVENT 980?

Accepted Answer

Ultramar Marketing Corp. filed the 510(k) submission for NEUMOVENT 980 (K821792).

Question 2

What is the FDA product code for NEUMOVENT 980?

Accepted Answer

CBK. It is classified under 21 CFR 868.5895 as a Class 2 device in the Anesthesiology panel.

Question 3

When was NEUMOVENT 980 cleared by the FDA?

Accepted Answer

Aug 2, 1982 (decision: SESE).

Question 4

What is the regulatory pathway for NEUMOVENT 980?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like NEUMOVENT 980?

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	K821792
Device Name	NEUMOVENT 980
Applicant	Ultramar Marketing Corp.
Product Code	CBK · Anesthesiology
Decision Date	Aug 2, 1982
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5895
Device Class	Class 2

NEUMOVENT 980

Device Facts

Regulatory Classification

Identification