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FDA 510(k)

ENDOSTEPPER 1

K-Number: K993188 · 1999-09-28

ApplicantPhytron- Elektronik GmbH
Decision Date1999-09-28
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDOSTEPPER 1 is the device name listed in this FDA 510(k) record. The listed applicant is Phytron- Elektronik GmbH. It received FDA 510(k) clearance on 1999-09-28 under 510(k) number K993188. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSTEPPER 1?

ENDOSTEPPER 1 is a medical device that received FDA 510(k) clearance on 1999-09-28. The listed applicant is Phytron- Elektronik GmbH. The 510(k) number is K993188.

When did ENDOSTEPPER 1 receive FDA 510(k) clearance?

ENDOSTEPPER 1 received FDA 510(k) clearance on 1999-09-28, under 510(k) number K993188.

Who is the listed applicant for ENDOSTEPPER 1?

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

What is the FDA product code for ENDOSTEPPER 1?

The FDA product code for ENDOSTEPPER 1 is EKX.

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Related Devices (Code: EKX)

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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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