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FDA 510(k)

ECLIPSE 6.5

K-Number: K010975 · 2001-05-02

ApplicantVarian Medical Systems, Inc.
Decision Date2001-05-02
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECLIPSE 6.5 is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2001-05-02 under 510(k) number K010975. 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 ECLIPSE 6.5?

ECLIPSE 6.5 is a medical device that received FDA 510(k) clearance on 2001-05-02. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K010975.

When did ECLIPSE 6.5 receive FDA 510(k) clearance?

ECLIPSE 6.5 received FDA 510(k) clearance on 2001-05-02, under 510(k) number K010975.

Who is the listed applicant for ECLIPSE 6.5?

The FDA 510(k) record lists Varian Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECLIPSE 6.5?

The FDA product code for ECLIPSE 6.5 is IYE.

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Other records listing Varian Medical Systems, Inc. as applicant

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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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