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FDA 510(k)

CT MAX 640 #B7940 JA/JE

K-Number: K882581 · 1988-08-15

ApplicantGeneral Electric Co.
Decision Date1988-08-15
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT MAX 640 #B7940 JA/JE 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 1988-08-15 under 510(k) number K882581. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CT MAX 640 #B7940 JA/JE?

CT MAX 640 #B7940 JA/JE is a medical device that received FDA 510(k) clearance on 1988-08-15. The listed applicant is General Electric Co.. The 510(k) number is K882581.

When did CT MAX 640 #B7940 JA/JE receive FDA 510(k) clearance?

CT MAX 640 #B7940 JA/JE received FDA 510(k) clearance on 1988-08-15, under 510(k) number K882581.

Who is the listed applicant for CT MAX 640 #B7940 JA/JE?

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 CT MAX 640 #B7940 JA/JE?

The FDA product code for CT MAX 640 #B7940 JA/JE is JAK.

Other records listing General Electric Co. as applicant

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Related Devices (Code: JAK)

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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