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FDA 510(k)

IMMOBILIZATION SYSTEM FOR ENT

K-Number: K003779 · 2001-07-12

ApplicantArplay Medical S.A.
Decision Date2001-07-12
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMMOBILIZATION SYSTEM FOR ENT 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 2001-07-12 under 510(k) number K003779. 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 IMMOBILIZATION SYSTEM FOR ENT?

IMMOBILIZATION SYSTEM FOR ENT is a medical device that received FDA 510(k) clearance on 2001-07-12. The listed applicant is Arplay Medical S.A.. The 510(k) number is K003779.

When did IMMOBILIZATION SYSTEM FOR ENT receive FDA 510(k) clearance?

IMMOBILIZATION SYSTEM FOR ENT received FDA 510(k) clearance on 2001-07-12, under 510(k) number K003779.

Who is the listed applicant for IMMOBILIZATION SYSTEM FOR ENT?

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 IMMOBILIZATION SYSTEM FOR ENT?

The FDA product code for IMMOBILIZATION SYSTEM FOR ENT 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.

K010065CRANIAL STEREOTACTIC EQUIPMENTK004023INTRA OPERATIVE RADIATION THERAPYK003778BREAST-BOARD (MULTIPLE)K010174TRAY ADAPTERS, MULTIPLEK010172LEAD BLOCKSK010063COUCH FOR TOTAL BODY RADIATION

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Related Devices (Code: IYE)

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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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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