Question 1

Who is the manufacturer of OXYLOG 2?

Accepted Answer

P.K. Morgan , Ltd. filed the 510(k) submission for OXYLOG 2 (K954731).

Question 2

What is the FDA product code for OXYLOG 2?

Accepted Answer

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

Question 3

When was OXYLOG 2 cleared by the FDA?

Accepted Answer

Jan 6, 1997 (decision: SESE).

Question 4

What is the regulatory pathway for OXYLOG 2?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like OXYLOG 2?

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	K954731
Device Name	OXYLOG 2
Applicant	P.K. Morgan , Ltd.
Product Code	BZL · Anesthesiology
Decision Date	Jan 6, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1730
Device Class	Class 2

OXYLOG 2

Device Facts

Regulatory Classification

Identification