Welcome to the official website of Reanny Group!

Reanny Medical Devices Management Consulting Co., Ltd.

Focused · dedicated · professional

Head Office

0755-27391220

Guangzhou Company

020-82513196

Cooperative Customer
Back
List

Good news - Congratulations to KWL wrist blood pressure monitor for obtaining K number

Congratulations to KWL for successfully obtaining the 510 (K) approval for wrist blood pressure monitors. The wrist blood pressure monitor went through more than two months from application to approval, and was approved after a round of rectification and improvement. Some of the supplementary content mainly involves partial revisions of third-party testing reports, software documentation, and manuals. After receiving the rectification requirements, we Notify the customer immediately to find a testing machine We will revise the report and be responsible for rectifying the remaining issues. Once the client receives the revised third-party testing report, we will immediately address it Submit all rectification materials to FDA as required. We received an email notification from the FDA regarding the approval of 510K within one month of submission.

It only takes about two months from submission to approval, which is inseparable from our registered teachers' familiarity and control of the product, regulations, audit requirements, and key points.

Ryan always uses expertise Our service attitude of professionalism, dedication, and high response speed helps customers quickly obtain certificates legally and compliantly, accelerate listing, and achieve economic benefits Great expansion!
Consult

Phone

Head Office

0755-27391220

Guangzhou Company

020-82513196

WeChat

Qrcode

WeChat customer service

Qrcode

Mini Program

Email

Enterprise Email

reanny@reanny.com