Question 1

Who is the manufacturer of OXY-OFF(TM)?

Accepted Answer

B&B Medical Technologies, Inc. filed the 510(k) submission for OXY-OFF(TM) (K863510).

Question 2

What is the FDA product code for OXY-OFF(TM)?

Accepted Answer

BXY. It is classified under 21 CFR 868.2350 as a Class 1 device in the Anesthesiology panel.

Question 3

When was OXY-OFF(TM) cleared by the FDA?

Accepted Answer

Oct 22, 1986 (decision: SESE).

Question 4

What is the regulatory pathway for OXY-OFF(TM)?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like OXY-OFF(TM)?

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	K863510
Device Name	OXY-OFF(TM)
Applicant	B&B Medical Technologies, Inc.
Product Code	BXY · Anesthesiology
Decision Date	Oct 22, 1986
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2350
Device Class	Class 1

OXY-OFF(TM)

Device Facts

Regulatory Classification

Identification