Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CompuFlo Epidural Computer Controlled Anesthesia System

K-Number: K161883 · 2017-06-09

ApplicantMilestone Scientific, Inc.
Decision Date2017-06-09
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CompuFlo Epidural Computer Controlled Anesthesia System is a medical device manufactured by Milestone Scientific, Inc.. It received FDA 510(k) clearance on 2017-06-09 under approval number K161883. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CompuFlo Epidural Computer Controlled Anesthesia System?

CompuFlo Epidural Computer Controlled Anesthesia System is a medical device that received FDA 510(k) clearance on 2017-06-09. It is manufactured by Milestone Scientific, Inc.. The 510(k) number is K161883.

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

CompuFlo Epidural Computer Controlled Anesthesia System received FDA 510(k) clearance on 2017-06-09, under approval number K161883.

What company makes CompuFlo Epidural Computer Controlled Anesthesia System?

CompuFlo Epidural Computer Controlled Anesthesia System is manufactured by Milestone Scientific, Inc..

What is the FDA product code for CompuFlo Epidural Computer Controlled Anesthesia System?

The FDA product code for CompuFlo Epidural Computer Controlled Anesthesia System is FMF.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT07610850 Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026)

Other Devices by Milestone Scientific, Inc.

K221702CompuFlo Epidural Computer Controlled Anesthesia System

Related Devices (Code: FMF)

K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd. K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeBecton, Dickinson and Company K162602NovoPen EchoNovo Nordisk, Inc. K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. K152879Sure-Fine Insulin SyringesShina Med Corporation K160629InPenCompanion Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑