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FDA 510(k)

SONOTT FLOWLAB(R)

K-Number: K111730 · 2012-01-06

ApplicantEm-Tec GmbH
Decision Date2012-01-06
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SONOTT FLOWLAB(R) is the device name listed in this FDA 510(k) record. The listed applicant is Em-Tec GmbH. It received FDA 510(k) clearance on 2012-01-06 under 510(k) number K111730. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOTT FLOWLAB(R)?

SONOTT FLOWLAB(R) is a medical device that received FDA 510(k) clearance on 2012-01-06. The listed applicant is Em-Tec GmbH. The 510(k) number is K111730.

When did SONOTT FLOWLAB(R) receive FDA 510(k) clearance?

SONOTT FLOWLAB(R) received FDA 510(k) clearance on 2012-01-06, under 510(k) number K111730.

Who is the listed applicant for SONOTT FLOWLAB(R)?

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

What is the FDA product code for SONOTT FLOWLAB(R)?

The FDA product code for SONOTT FLOWLAB(R) is DPW.

Related Clinical Trials

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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Other records listing Em-Tec 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.

K080704LOW FLUID ALARMK040909SONO TT ULTRASONIC FLOWCOMPUTER

Related Devices (Code: DPW)

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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