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FDA 510(k)

SATURNE 41

K-Number: K892860 · 1989-06-23

ApplicantGeneral Electric Co.
Decision Date1989-06-23
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SATURNE 41 is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K892860. 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 SATURNE 41?

SATURNE 41 is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is General Electric Co.. The 510(k) number is K892860.

When did SATURNE 41 receive FDA 510(k) clearance?

SATURNE 41 received FDA 510(k) clearance on 1989-06-23, under 510(k) number K892860.

Who is the listed applicant for SATURNE 41?

The FDA 510(k) record lists General Electric Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SATURNE 41?

The FDA product code for SATURNE 41 is 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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