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FDA 510(k)

Q-SMART HOLTER SYSTEMS

K-Number: K910808 · 1991-07-17

ApplicantQuinton, Inc.
Decision Date1991-07-17
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Q-SMART HOLTER SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1991-07-17 under 510(k) number K910808. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Q-SMART HOLTER SYSTEMS?

Q-SMART HOLTER SYSTEMS is a medical device that received FDA 510(k) clearance on 1991-07-17. The listed applicant is Quinton, Inc.. The 510(k) number is K910808.

When did Q-SMART HOLTER SYSTEMS receive FDA 510(k) clearance?

Q-SMART HOLTER SYSTEMS received FDA 510(k) clearance on 1991-07-17, under 510(k) number K910808.

Who is the listed applicant for Q-SMART HOLTER SYSTEMS?

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

What is the FDA product code for Q-SMART HOLTER SYSTEMS?

The FDA product code for Q-SMART HOLTER SYSTEMS is DSI.

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Other records listing Quinton, Inc. as applicant

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Related Devices (Code: DSI)

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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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