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FDA 510(k)

SERIES 620 RECTAL PROBE COVER

K-Number: K864222 · 1987-03-04

ApplicantGeneral Electric Co.
Decision Date1987-03-04
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SERIES 620 RECTAL PROBE COVER 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 1987-03-04 under 510(k) number K864222. 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 SERIES 620 RECTAL PROBE COVER?

SERIES 620 RECTAL PROBE COVER is a medical device that received FDA 510(k) clearance on 1987-03-04. The listed applicant is General Electric Co.. The 510(k) number is K864222.

When did SERIES 620 RECTAL PROBE COVER receive FDA 510(k) clearance?

SERIES 620 RECTAL PROBE COVER received FDA 510(k) clearance on 1987-03-04, under 510(k) number K864222.

Who is the listed applicant for SERIES 620 RECTAL PROBE COVER?

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 SERIES 620 RECTAL PROBE COVER?

The FDA product code for SERIES 620 RECTAL PROBE COVER 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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