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FDA 510(k)

SIII ALARM AMPLIFIER

K-Number: K011088 · 2001-05-02

ApplicantStockert Instrumente GmbH
Decision Date2001-05-02
Product CodeDTQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIII ALARM AMPLIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Stockert Instrumente GmbH. It received FDA 510(k) clearance on 2001-05-02 under 510(k) number K011088. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIII ALARM AMPLIFIER?

SIII ALARM AMPLIFIER is a medical device that received FDA 510(k) clearance on 2001-05-02. The listed applicant is Stockert Instrumente GmbH. The 510(k) number is K011088.

When did SIII ALARM AMPLIFIER receive FDA 510(k) clearance?

SIII ALARM AMPLIFIER received FDA 510(k) clearance on 2001-05-02, under 510(k) number K011088.

Who is the listed applicant for SIII ALARM AMPLIFIER?

The FDA 510(k) record lists Stockert Instrumente GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIII ALARM AMPLIFIER?

The FDA product code for SIII ALARM AMPLIFIER is DTQ.

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Other records listing Stockert Instrumente GmbH 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.

K042374STOCKERT SCP RHYTHMK041558STOCKERTIR PURGE CONTROL (APC) SYSTEMK032213STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMPK023622STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35K022280STOCKERT CORONARY PERFUSION CANNULAEK022321STOCKERT V172-28 VENOUS FEMORAL CANNULA

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Related Devices (Code: DTQ)

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.

K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbHK221895Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationK221373Essenz HLMLivanova Deutschland, GmbHK210130Stockert S5 SystemLivanova Deutschland, GmbHK202125Century Perfusion SystemCentury Hlm, LLCK190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)Spectrum Medical , Ltd.

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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