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FDA 510(k)

CRANIAL STEREOTACTIC EQUIPMENT

K-Number: K010065 · 2002-07-02

ApplicantArplay Medical S.A.
Decision Date2002-07-02
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CRANIAL STEREOTACTIC EQUIPMENT is the device name listed in this FDA 510(k) record. The listed applicant is Arplay Medical S.A.. It received FDA 510(k) clearance on 2002-07-02 under 510(k) number K010065. 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 CRANIAL STEREOTACTIC EQUIPMENT?

CRANIAL STEREOTACTIC EQUIPMENT is a medical device that received FDA 510(k) clearance on 2002-07-02. The listed applicant is Arplay Medical S.A.. The 510(k) number is K010065.

When did CRANIAL STEREOTACTIC EQUIPMENT receive FDA 510(k) clearance?

CRANIAL STEREOTACTIC EQUIPMENT received FDA 510(k) clearance on 2002-07-02, under 510(k) number K010065.

Who is the listed applicant for CRANIAL STEREOTACTIC EQUIPMENT?

The FDA 510(k) record lists Arplay Medical S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRANIAL STEREOTACTIC EQUIPMENT?

The FDA product code for CRANIAL STEREOTACTIC EQUIPMENT is IYE.

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Other records listing Arplay Medical S.A. 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.

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Related Devices (Code: IYE)

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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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