Question 1

Who is the manufacturer of CALIBRATION GAS?

Accepted Answer

Sunox, Inc. filed the 510(k) submission for CALIBRATION GAS (K944998).

Question 2

What is the FDA product code for CALIBRATION GAS?

Accepted Answer

BXK. It is classified under 21 CFR 868.6400 as a Class 1 device in the Anesthesiology panel.

Question 3

When was CALIBRATION GAS cleared by the FDA?

Accepted Answer

Feb 3, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for CALIBRATION GAS?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like CALIBRATION GAS?

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	K944998
Device Name	CALIBRATION GAS
Applicant	Sunox, Inc.
Product Code	BXK · Anesthesiology
Decision Date	Feb 3, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.6400
Device Class	Class 1

CALIBRATION GAS

Device Facts

Regulatory Classification

Identification