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FDA 510(k)

Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S

K-Number: K082173 · 2008-08-26

ApplicantCardiac Science Corporation
Decision Date2008-08-26
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Science Corporation. It received FDA 510(k) clearance on 2008-08-26 under 510(k) number K082173. 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 Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S?

Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S is a medical device that received FDA 510(k) clearance on 2008-08-26. The listed applicant is Cardiac Science Corporation. The 510(k) number is K082173.

When did Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S receive FDA 510(k) clearance?

Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S received FDA 510(k) clearance on 2008-08-26, under 510(k) number K082173.

Who is the listed applicant for Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S?

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

What is the FDA product code for Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S?

The FDA product code for Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S is DPS.

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Related Devices (Code: DPS)

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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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