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FDA 510(k)

FORA P100 Blood Pressure Monitoring System

K-Number: K182934 · 2019-02-12

Decision Date2019-02-12
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FORA P100 Blood Pressure Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Taidoc Technology Corporation. It received FDA 510(k) clearance on 2019-02-12 under 510(k) number K182934. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORA P100 Blood Pressure Monitoring System?

FORA P100 Blood Pressure Monitoring System is a medical device that received FDA 510(k) clearance on 2019-02-12. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K182934.

When did FORA P100 Blood Pressure Monitoring System receive FDA 510(k) clearance?

FORA P100 Blood Pressure Monitoring System received FDA 510(k) clearance on 2019-02-12, under 510(k) number K182934.

Who is the listed applicant for FORA P100 Blood Pressure Monitoring System?

The FDA 510(k) record lists Taidoc Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FORA P100 Blood Pressure Monitoring System?

The FDA product code for FORA P100 Blood Pressure Monitoring System is DXN.

Other records listing Taidoc Technology Corporation 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.

View all 17 devices →

Related Devices (Code: DXN)

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.

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.