Question 1

Who is the manufacturer of MEDGRAPHICS PF/DX?

Accepted Answer

Medical Graphics Corp. filed the 510(k) submission for MEDGRAPHICS PF/DX (K912906).

Question 2

What is the FDA product code for MEDGRAPHICS PF/DX?

Accepted Answer

BZL. It is classified under 21 CFR 868.1730 as a Class 2 device in the Anesthesiology panel.

Question 3

When was MEDGRAPHICS PF/DX cleared by the FDA?

Accepted Answer

Feb 4, 1992 (decision: SESE).

Question 4

What is the regulatory pathway for MEDGRAPHICS PF/DX?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MEDGRAPHICS PF/DX?

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	K912906
Device Name	MEDGRAPHICS PF/DX
Applicant	Medical Graphics Corp.
Product Code	BZL · Anesthesiology
Decision Date	Feb 4, 1992
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1730
Device Class	Class 2

MEDGRAPHICS PF/DX

Device Facts

Regulatory Classification

Identification