Question 1

Who is the manufacturer of NO-FLO I?

Accepted Answer

Design Technologies, Inc. filed the 510(k) submission for NO-FLO I (K863613).

Question 2

What is the FDA product code for NO-FLO I?

Accepted Answer

CCN. It is classified under 21 CFR 868.2300 as a Class 1 device in the Anesthesiology panel.

Question 3

When was NO-FLO I cleared by the FDA?

Accepted Answer

Dec 15, 1986 (decision: SESE).

Question 4

What is the regulatory pathway for NO-FLO I?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like NO-FLO I?

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	K863613
Device Name	NO-FLO I
Applicant	Design Technologies, Inc.
Product Code	CCN · Anesthesiology
Decision Date	Dec 15, 1986
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2300
Device Class	Class 1

NO-FLO I

Device Facts

Regulatory Classification

Identification