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FDA 510(k)

TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A

K-Number: K071075 · 2007-05-25

ApplicantTerumo Corp.
Decision Date2007-05-25
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corp.. It received FDA 510(k) clearance on 2007-05-25 under 510(k) number K071075. 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 TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A?

TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A is a medical device that received FDA 510(k) clearance on 2007-05-25. The listed applicant is Terumo Corp.. The 510(k) number is K071075.

When did TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A receive FDA 510(k) clearance?

TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A received FDA 510(k) clearance on 2007-05-25, under 510(k) number K071075.

Who is the listed applicant for TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A?

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

What is the FDA product code for TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A?

The FDA product code for TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A is DXN.

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Other records listing Terumo Corp. as applicant

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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.

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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.

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