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FDA 510(k)

SCOUTPRO ACS

K-Number: K101776 · 2010-07-23

ApplicantBiotronik, Inc.
Decision Date2010-07-23
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCOUTPRO ACS is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2010-07-23 under 510(k) number K101776. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCOUTPRO ACS?

SCOUTPRO ACS is a medical device that received FDA 510(k) clearance on 2010-07-23. The listed applicant is Biotronik, Inc.. The 510(k) number is K101776.

When did SCOUTPRO ACS receive FDA 510(k) clearance?

SCOUTPRO ACS received FDA 510(k) clearance on 2010-07-23, under 510(k) number K101776.

Who is the listed applicant for SCOUTPRO ACS?

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

What is the FDA product code for SCOUTPRO ACS?

The FDA product code for SCOUTPRO ACS is DQY.

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Other records listing Biotronik, Inc. as applicant

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Related Devices (Code: DQY)

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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