Question 1

Who is the manufacturer of MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM?

Accepted Answer

Ametek/Thermox Instruments Division filed the 510(k) submission for MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM (K874663).

Question 2

What is the FDA product code for MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM?

Accepted Answer

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

Question 3

When was MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM cleared by the FDA?

Accepted Answer

May 31, 1988 (decision: SESE).

Question 4

What is the regulatory pathway for MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM?

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	K874663
Device Name	MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM
Applicant	Ametek/Thermox Instruments Division
Product Code	BZL · Anesthesiology
Decision Date	May 31, 1988
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1730
Device Class	Class 2

MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM

Device Facts

Regulatory Classification

Identification