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FDA 510(k)

BI-PLANE TRANSRECTAL PROBE NUMBER H4221T

K-Number: K862911 · 1986-10-31

ApplicantGeneral Electric Co.
Decision Date1986-10-31
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BI-PLANE TRANSRECTAL PROBE NUMBER H4221T 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 1986-10-31 under 510(k) number K862911. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BI-PLANE TRANSRECTAL PROBE NUMBER H4221T?

BI-PLANE TRANSRECTAL PROBE NUMBER H4221T is a medical device that received FDA 510(k) clearance on 1986-10-31. The listed applicant is General Electric Co.. The 510(k) number is K862911.

When did BI-PLANE TRANSRECTAL PROBE NUMBER H4221T receive FDA 510(k) clearance?

BI-PLANE TRANSRECTAL PROBE NUMBER H4221T received FDA 510(k) clearance on 1986-10-31, under 510(k) number K862911.

Who is the listed applicant for BI-PLANE TRANSRECTAL PROBE NUMBER H4221T?

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 BI-PLANE TRANSRECTAL PROBE NUMBER H4221T?

The FDA product code for BI-PLANE TRANSRECTAL PROBE NUMBER H4221T is ITX.

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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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