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

FDA 510(k)

PETITE BASIC SYSTEM 701 ELT

K-Number: K131420 · 2013-11-01

ApplicantMego Afek AC , Ltd.
Decision Date2013-11-01
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PETITE BASIC SYSTEM 701 ELT is the device name listed in this FDA 510(k) record. The listed applicant is Mego Afek AC , Ltd.. It received FDA 510(k) clearance on 2013-11-01 under 510(k) number K131420. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PETITE BASIC SYSTEM 701 ELT?

PETITE BASIC SYSTEM 701 ELT is a medical device that received FDA 510(k) clearance on 2013-11-01. The listed applicant is Mego Afek AC , Ltd.. The 510(k) number is K131420.

When did PETITE BASIC SYSTEM 701 ELT receive FDA 510(k) clearance?

PETITE BASIC SYSTEM 701 ELT received FDA 510(k) clearance on 2013-11-01, under 510(k) number K131420.

Who is the listed applicant for PETITE BASIC SYSTEM 701 ELT?

The FDA 510(k) record lists Mego Afek AC , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PETITE BASIC SYSTEM 701 ELT?

The FDA product code for PETITE BASIC SYSTEM 701 ELT is JOW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mego Afek AC , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K214053Amputee Garment for use with Lympha Press Optimal PlusK190493Recovery Pump, 737R (RPX)K190015Ballancer Gold, 1212K182003Lympha Press Optimal PlusK172277Phlebo Press DVT ModelK170658Lympha Press Optimal Plus

View all 13 devices →

Related Devices (Code: JOW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.

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.

↑