Question 1

Who is the manufacturer of FLOW=MED?

Accepted Answer

International Electronic Technology Corp. filed the 510(k) submission for FLOW=MED (K924322).

Question 2

What is the FDA product code for FLOW=MED?

Accepted Answer

BZH. It is classified under 21 CFR 868.1860 as a Class 2 device in the Anesthesiology panel.

Question 3

When was FLOW=MED cleared by the FDA?

Accepted Answer

Apr 26, 1994 (decision: SESE).

Question 4

What is the regulatory pathway for FLOW=MED?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like FLOW=MED?

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	K924322
Device Name	FLOW=MED
Applicant	International Electronic Technology Corp.
Product Code	BZH · Anesthesiology
Decision Date	Apr 26, 1994
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1860
Device Class	Class 2

FLOW=MED

Device Facts

Regulatory Classification

Identification