Question 1

Who is the manufacturer of PM-3?

Accepted Answer

Delta Medical Industries filed the 510(k) submission for PM-3 (K831750).

Question 2

What is the FDA product code for PM-3?

Accepted Answer

DXS. It is classified under 21 CFR 870.4310 as a Class 2 device in the Cardiovascular panel.

Question 3

When was PM-3 cleared by the FDA?

Accepted Answer

Jul 26, 1983 (decision: SESE).

Question 4

What is the regulatory pathway for PM-3?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like PM-3?

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	K831750
Device Name	PM-3
Applicant	Delta Medical Industries
Product Code	DXS · Cardiovascular
Decision Date	Jul 26, 1983
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4310
Device Class	Class 2

PM-3

Device Facts

Regulatory Classification

Identification