CompuFlo Epidural Computer Controlled Anesthesia System

FDA 510(k) K161883 · Milestone Scientific, Inc.

Substantially Equivalent

510(k) numberK161883

Submission

Device name
CompuFlo Epidural Computer Controlled Anesthesia System
Applicant
Milestone Scientific, Inc.
Livingston, NJ, US
Received
July 11, 2016
Decision date
June 9, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FMF – Syringe, Piston
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5860
Specialty
General Hospital

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More from Instylla, Inc.

510(k)DeviceDecision
K221702CompuFlo Epidural Computer Controlled Anesthesia SystemFMF · Traditional 02/25/2023SE
K061904Compudent StaEJI · Traditional 08/08/2006SE
K053554CompufloFRN · Traditional 07/10/2006SE

Questions and answers

When was CompuFlo Epidural Computer Controlled Anesthesia System cleared by the FDA?

CompuFlo Epidural Computer Controlled Anesthesia System (K161883) received a 510(k) decision of Substantially Equivalent on June 9, 2017, 333 days after the submission was received.

What is the product code of K161883?

The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.