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FDA 510(k)

RFA-1717DIG, RFA-1717DIC

K-Number: K212051 · 2021-08-25

ApplicantAstel, Inc.
Decision Date2021-08-25
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RFA-1717DIG, RFA-1717DIC is a medical device manufactured by Astel, Inc.. It received FDA 510(k) clearance on 2021-08-25 under approval number K212051. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RFA-1717DIG, RFA-1717DIC?

RFA-1717DIG, RFA-1717DIC is a medical device that received FDA 510(k) clearance on 2021-08-25. It is manufactured by Astel, Inc.. The 510(k) number is K212051.

When was RFA-1717DIG, RFA-1717DIC approved by the FDA?

RFA-1717DIG, RFA-1717DIC received FDA 510(k) clearance on 2021-08-25, under approval number K212051.

What company makes RFA-1717DIG, RFA-1717DIC?

RFA-1717DIG, RFA-1717DIC is manufactured by Astel, Inc..

What is the FDA product code for RFA-1717DIG, RFA-1717DIC?

The FDA product code for RFA-1717DIG, RFA-1717DIC is MQB.

Related Devices (Code: MQB)

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.