FDA 510(k)

SP-1000, SP-2000

K-Number: K202395 · 2021-09-01

Decision Date2021-09-01

Product CodeIRP

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

SP-1000, SP-2000 is a medical device manufactured by Daesung Maref Co., Ltd.. It received FDA 510(k) clearance on 2021-09-01 under approval number K202395. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SP-1000, SP-2000?

SP-1000, SP-2000 is a medical device that received FDA 510(k) clearance on 2021-09-01. It is manufactured by Daesung Maref Co., Ltd.. The 510(k) number is K202395.

When was SP-1000, SP-2000 approved by the FDA?

SP-1000, SP-2000 received FDA 510(k) clearance on 2021-09-01, under approval number K202395.

What company makes SP-1000, SP-2000?

SP-1000, SP-2000 is manufactured by Daesung Maref Co., Ltd..

What is the FDA product code for SP-1000, SP-2000?

The FDA product code for SP-1000, SP-2000 is IRP.

Other Devices by Daesung Maref Co., Ltd.

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Related Devices (Code: IRP)

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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.