Question 1

Who is the manufacturer of HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE?

Accepted Answer

Hewlett-Packard Co. filed the 510(k) submission for HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE (K903523).

Question 2

What is the FDA product code for HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE?

Accepted Answer

DQA. It is classified under 21 CFR 870.2700 as a Class 2 device in the Cardiovascular panel.

Question 3

When was HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE cleared by the FDA?

Accepted Answer

Oct 23, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE?

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	K903523
Device Name	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE
Applicant	Hewlett-Packard Co.
Product Code	DQA · Cardiovascular
Decision Date	Oct 23, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2700
Device Class	Class 2

HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE

Device Facts

Regulatory Classification

Identification