Question 1

Who is the manufacturer of SELECT FLOWMETER?

Accepted Answer

Precision Medical, Inc. filed the 510(k) submission for SELECT FLOWMETER (K854067).

Question 2

What is the FDA product code for SELECT FLOWMETER?

Accepted Answer

CAX. It is classified under 21 CFR 868.2340 as a Class 1 device in the Anesthesiology panel.

Question 3

When was SELECT FLOWMETER cleared by the FDA?

Accepted Answer

Oct 29, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for SELECT FLOWMETER?

Accepted Answer

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

Question 5

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

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	K854067
Device Name	SELECT FLOWMETER
Applicant	Precision Medical, Inc.
Product Code	CAX · Anesthesiology
Decision Date	Oct 29, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2340
Device Class	Class 1

SELECT FLOWMETER

Device Facts

Regulatory Classification

Identification