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FDA 510(k)

APOLLO 5, APOLLO 10

K-Number: K990383 · 1999-05-05

ApplicantPrecitron A.B.
Decision Date1999-05-05
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

APOLLO 5, APOLLO 10 is the device name listed in this FDA 510(k) record. The listed applicant is Precitron A.B.. It received FDA 510(k) clearance on 1999-05-05 under 510(k) number K990383. 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 APOLLO 5, APOLLO 10?

APOLLO 5, APOLLO 10 is a medical device that received FDA 510(k) clearance on 1999-05-05. The listed applicant is Precitron A.B.. The 510(k) number is K990383.

When did APOLLO 5, APOLLO 10 receive FDA 510(k) clearance?

APOLLO 5, APOLLO 10 received FDA 510(k) clearance on 1999-05-05, under 510(k) number K990383.

Who is the listed applicant for APOLLO 5, APOLLO 10?

The FDA 510(k) record lists Precitron A.B. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APOLLO 5, APOLLO 10?

The FDA product code for APOLLO 5, APOLLO 10 is IYE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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