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FDA 510(k)

HRV TOOLS

K-Number: K040313 · 2004-04-06

ApplicantDel Mar Reynolds Medical, Ltd.
Decision Date2004-04-06
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HRV TOOLS is the device name listed in this FDA 510(k) record. The listed applicant is Del Mar Reynolds Medical, Ltd.. It received FDA 510(k) clearance on 2004-04-06 under 510(k) number K040313. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HRV TOOLS?

HRV TOOLS is a medical device that received FDA 510(k) clearance on 2004-04-06. The listed applicant is Del Mar Reynolds Medical, Ltd.. The 510(k) number is K040313.

When did HRV TOOLS receive FDA 510(k) clearance?

HRV TOOLS received FDA 510(k) clearance on 2004-04-06, under 510(k) number K040313.

Who is the listed applicant for HRV TOOLS?

The FDA 510(k) record lists Del Mar Reynolds Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HRV TOOLS?

The FDA product code for HRV TOOLS is DPS.

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Other records listing Del Mar Reynolds Medical, Ltd. 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.

K062397SENTINELK062469VOYAGER 12K051960CARDIONAVIGATOR +

Related Devices (Code: DPS)

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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