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FDA 510(k)

SP-1000, SP-2000

K-Number: K202395 · 2021-09-01

ApplicantDaesung Maref Co., Ltd.
Decision Date2021-09-01
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SP-1000, SP-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Daesung Maref Co., Ltd.. It received FDA 510(k) clearance on 2021-09-01 under 510(k) 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. The listed applicant is Daesung Maref Co., Ltd.. The 510(k) number is K202395.

When did SP-1000, SP-2000 receive FDA 510(k) clearance?

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

Who is the listed applicant for SP-1000, SP-2000?

The FDA 510(k) record lists Daesung Maref Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Daesung Maref Co., Ltd. as applicant

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Related Devices (Code: IRP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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