Question 1

Who is the manufacturer of OMNISTICK?

Accepted Answer

Marquest Medical Products, Inc. filed the 510(k) submission for OMNISTICK (K830310).

Question 2

What is the FDA product code for OMNISTICK?

Accepted Answer

CBT. It is classified under 21 CFR 868.1100 as a Class 1 device in the Anesthesiology panel.

Question 3

When was OMNISTICK cleared by the FDA?

Accepted Answer

May 25, 1983 (decision: SESE).

Question 4

What is the regulatory pathway for OMNISTICK?

Accepted Answer

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

Question 5

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

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	K830310
Device Name	OMNISTICK
Applicant	Marquest Medical Products, Inc.
Product Code	CBT · Anesthesiology
Decision Date	May 25, 1983
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1100
Device Class	Class 1

OMNISTICK

Device Facts

Regulatory Classification

Identification