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FDA 510(k)

SAGE 7

K-Number: K984167 · 1999-01-12

ApplicantGE Medical Systems
Decision Date1999-01-12
Product CodeLNI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SAGE 7 is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 1999-01-12 under 510(k) number K984167. The device is classified under product code LNI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAGE 7?

SAGE 7 is a medical device that received FDA 510(k) clearance on 1999-01-12. The listed applicant is GE Medical Systems. The 510(k) number is K984167.

When did SAGE 7 receive FDA 510(k) clearance?

SAGE 7 received FDA 510(k) clearance on 1999-01-12, under 510(k) number K984167.

Who is the listed applicant for SAGE 7?

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

What is the FDA product code for SAGE 7?

The FDA product code for SAGE 7 is LNI.

Other records listing GE Medical Systems as applicant

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Related Devices (Code: LNI)

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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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