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FDA 510(k)

ERGOSELECT/GE

K-Number: K112121 · 2012-10-31

ApplicantErgoline GmbH
Decision Date2012-10-31
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ERGOSELECT/GE is the device name listed in this FDA 510(k) record. The listed applicant is Ergoline GmbH. It received FDA 510(k) clearance on 2012-10-31 under 510(k) number K112121. The device is classified under product code ISD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERGOSELECT/GE?

ERGOSELECT/GE is a medical device that received FDA 510(k) clearance on 2012-10-31. The listed applicant is Ergoline GmbH. The 510(k) number is K112121.

When did ERGOSELECT/GE receive FDA 510(k) clearance?

ERGOSELECT/GE received FDA 510(k) clearance on 2012-10-31, under 510(k) number K112121.

Who is the listed applicant for ERGOSELECT/GE?

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

What is the FDA product code for ERGOSELECT/GE?

The FDA product code for ERGOSELECT/GE is ISD.

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 Ergoline 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.

K212883ers2 - ergoline Rehabilitation SystemK053078ERGOSELECT 100 K/P, ERGOSELECT 200 K/P

Related Devices (Code: ISD)

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.

K202979MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal UltraLode B.V.K183296REAL Immersive SystemPenumbra, Inc.K080545ACTITRAINERActigraph, LLCK053078ERGOSELECT 100 K/P, ERGOSELECT 200 K/PErgoline GmbHK990866QUINTON MEDTRACK CR PLUS TREADMILLQuinton, Inc.K990813REHCORElectromed Corp.

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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