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FDA 510(k)

DATASON RTL II

K-Number: K802695 · 1981-01-07

ApplicantGeneral Electric Co.
Decision Date1981-01-07
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DATASON RTL II 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 1981-01-07 under 510(k) number K802695. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DATASON RTL II?

DATASON RTL II is a medical device that received FDA 510(k) clearance on 1981-01-07. The listed applicant is General Electric Co.. The 510(k) number is K802695.

When did DATASON RTL II receive FDA 510(k) clearance?

DATASON RTL II received FDA 510(k) clearance on 1981-01-07, under 510(k) number K802695.

Who is the listed applicant for DATASON RTL II?

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 DATASON RTL II?

The FDA product code for DATASON RTL II is IYO.

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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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