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FDA 510(k)

ERGOSELECT 100 K/P, ERGOSELECT 200 K/P

K-Number: K053078 · 2006-04-27

ApplicantErgoline GmbH
Decision Date2006-04-27
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ERGOSELECT 100 K/P, ERGOSELECT 200 K/P is the device name listed in this FDA 510(k) record. The listed applicant is Ergoline GmbH. It received FDA 510(k) clearance on 2006-04-27 under 510(k) number K053078. 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 100 K/P, ERGOSELECT 200 K/P?

ERGOSELECT 100 K/P, ERGOSELECT 200 K/P is a medical device that received FDA 510(k) clearance on 2006-04-27. The listed applicant is Ergoline GmbH. The 510(k) number is K053078.

When did ERGOSELECT 100 K/P, ERGOSELECT 200 K/P receive FDA 510(k) clearance?

ERGOSELECT 100 K/P, ERGOSELECT 200 K/P received FDA 510(k) clearance on 2006-04-27, under 510(k) number K053078.

Who is the listed applicant for ERGOSELECT 100 K/P, ERGOSELECT 200 K/P?

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 100 K/P, ERGOSELECT 200 K/P?

The FDA product code for ERGOSELECT 100 K/P, ERGOSELECT 200 K/P 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 SystemK112121ERGOSELECT/GE

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.K112121ERGOSELECT/GEErgoline GmbHK080545ACTITRAINERActigraph, LLCK990866QUINTON MEDTRACK CR PLUS TREADMILLQuinton, Inc.K990813REHCORElectromed Corp.

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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