Question 1

Who is the manufacturer of NGM FRAME?

Accepted Answer

Datex Division Instrumentarium Corp. filed the 510(k) submission for NGM FRAME (K911644).

Question 2

What is the FDA product code for NGM FRAME?

Accepted Answer

CBQ. It is classified under 21 CFR 868.1500 as a Class 2 device in the Anesthesiology panel.

Question 3

When was NGM FRAME cleared by the FDA?

Accepted Answer

Mar 4, 1992 (decision: SESE).

Question 4

What is the regulatory pathway for NGM FRAME?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like NGM FRAME?

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	K911644
Device Name	NGM FRAME
Applicant	Datex Division Instrumentarium Corp.
Product Code	CBQ · Anesthesiology
Decision Date	Mar 4, 1992
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1500
Device Class	Class 2

NGM FRAME

Device Facts

Regulatory Classification

Identification