Question 1

Who is the manufacturer of PB GRAPHICS PRINTER AND PB VIDEO DISPLAY?

Accepted Answer

Datex Division Instrumentarium Corp. filed the 510(k) submission for PB GRAPHICS PRINTER AND PB VIDEO DISPLAY (K863248).

Question 2

What is the FDA product code for PB GRAPHICS PRINTER AND PB VIDEO DISPLAY?

Accepted Answer

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

Question 3

When was PB GRAPHICS PRINTER AND PB VIDEO DISPLAY cleared by the FDA?

Accepted Answer

Sep 3, 1986 (decision: SESE).

Question 4

What is the regulatory pathway for PB GRAPHICS PRINTER AND PB VIDEO DISPLAY?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like PB GRAPHICS PRINTER AND PB VIDEO DISPLAY?

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	K863248
Device Name	PB GRAPHICS PRINTER AND PB VIDEO DISPLAY
Applicant	Datex Division Instrumentarium Corp.
Product Code	CBQ · Anesthesiology
Decision Date	Sep 3, 1986
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1500
Device Class	Class 2

PB GRAPHICS PRINTER AND PB VIDEO DISPLAY

Device Facts

Regulatory Classification

Identification