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FDA 510(k)

TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT

K-Number: K062342 · 2006-09-25

ApplicantSentra Medical Devices, LLC
Decision Date2006-09-25
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sentra Medical Devices, LLC. It received FDA 510(k) clearance on 2006-09-25 under 510(k) number K062342. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT?

TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT is a medical device that received FDA 510(k) clearance on 2006-09-25. The listed applicant is Sentra Medical Devices, LLC. The 510(k) number is K062342.

When did TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT receive FDA 510(k) clearance?

TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT received FDA 510(k) clearance on 2006-09-25, under 510(k) number K062342.

Who is the listed applicant for TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT?

The FDA 510(k) record lists Sentra Medical Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT?

The FDA product code for TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT is DRS.

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Related Devices (Code: DRS)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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