Syrma Johari Medtech Ltd.
  • ABOUT US
  • SERVICES
    • DESIGN & ENGINEERING
    • CONTRACT MANUFACTURING
    • PCBA
    • FULL MEDICAL DEVICE LIFECYCLE
    • QARA
  • PRODUCT EXPERTISE
    • BIOELECTRICAL STIMULATION
    • PATIENT MONITORING
    • DIAGNOSTICS
    • OPTICAL IMAGING
    • ENERGY BASED DEVICES
    • PERSONAL USE
  • RESOURCES
    • BLOGS
    • CASE STUDIES
    • NEWS & EVENTS
    • WEBINARS
    • WHITE PAPERS
    • THOUGHT LEADERSHIP
  • CONTACT US
Select Page

510(k) Approval Process : A Comprehensive Guide

by Syrma Johari MedTech | Jan 13, 2022 | Blog

Getting your Class II Medical Device in US Market requires several steps of 510k clearance. Before you begin the submission it’s necessary to understand,  what is exactly 510k? Medical Device Manufacturers and Developers must be ready with required documents to ensure...
Page 1 of 11

Recent Posts

  • Top 8 Fluorescence Immunoassay Technology Trends to Know
  • QARA-Centric Manufacturing: Embedding Regulatory Compliance into Every Stage of Medical Device Manufacturing
  • Tariff Engineering for Medical Devices: A Strategic Approach to Cost Optimization
  • Beyond Tariff Waves: Building Enduring Medtech Supply Chains – Part One
  • In Vitro Diagnostics (IVD) Growth & Trends: Clinical Impact Meets Commercial Opportunity
  • Syrma Johari MedTech at The MedTech Conference 2025: Connecting with Global MedTech Leaders
  • Strengthening Supplier Assessment in Medical Devices: Best Practices for Quality, Compliance, and Risk Mitigation
  • Global Regulatory Submissions for Medical Devices
  • Syrma Johari MedTech Wins “Service Provider of the Year” at ET Healthcare Awards 2025
  • Medical Device Contract Manufacturing: How to Choose the Right Partner
  • Career At Syrma Johari
  • Privacy Policy
  • CSR Policy
  • CSR Activities
  • ESG Initiatives
  • Contact Us

SERVICES

  • Design and Engineering
  • Contract Manufacturing
  • PCBA
  • QARA Services

MAKE IN INDIA FOR THE WORLD

BLOGS

Product Expertise

  • Bio Electrical Stimulation
  • Patient Monitoring
  • Diagnostic & Lab Equipment
  • Optical Imaging
  • Energy Based Devices
  • Personal Use Devices
SyrmaJohariMedTech_logo
© 2025, Syrma Johari MedTech Ltd. All rights reserved.