Question 1

Who is the manufacturer of PPM III?

Accepted Answer

O-Two Systems Intl., Inc. filed the 510(k) submission for PPM III (K940712).

Question 2

What is the FDA product code for PPM III?

Accepted Answer

CBP. It is classified under 21 CFR 868.5870 as a Class 2 device in the Anesthesiology panel.

Question 3

When was PPM III cleared by the FDA?

Accepted Answer

Nov 14, 1994 (decision: SESE).

Question 4

What is the regulatory pathway for PPM III?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like PPM III?

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	K940712
Device Name	PPM III
Applicant	O-Two Systems Intl., Inc.
Product Code	CBP · Anesthesiology
Decision Date	Nov 14, 1994
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5870
Device Class	Class 2

PPM III

Device Facts

Regulatory Classification

Identification