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FDA 510(k)

BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST

K-Number: K081218 · 2008-07-21

ApplicantIt-V Medizintechnik, GmbH
Decision Date2008-07-21
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST is the device name listed in this FDA 510(k) record. The listed applicant is It-V Medizintechnik, GmbH. It received FDA 510(k) clearance on 2008-07-21 under 510(k) number K081218. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST?

BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST is a medical device that received FDA 510(k) clearance on 2008-07-21. The listed applicant is It-V Medizintechnik, GmbH. The 510(k) number is K081218.

When did BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST receive FDA 510(k) clearance?

BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST received FDA 510(k) clearance on 2008-07-21, under 510(k) number K081218.

Who is the listed applicant for BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST?

The FDA 510(k) record lists It-V Medizintechnik, GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST?

The FDA product code for BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST is IYE.

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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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