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FDA 510(k)

Lympha-Flow(LF1200)

K-Number: K160178 · 2017-01-11

Decision Date2017-01-11
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Lympha-Flow(LF1200) 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 2017-01-11 under 510(k) number K160178. 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 Lympha-Flow(LF1200)?

Lympha-Flow(LF1200) is a medical device that received FDA 510(k) clearance on 2017-01-11. The listed applicant is Daesung Maref Co., Ltd.. The 510(k) number is K160178.

When did Lympha-Flow(LF1200) receive FDA 510(k) clearance?

Lympha-Flow(LF1200) received FDA 510(k) clearance on 2017-01-11, under 510(k) number K160178.

Who is the listed applicant for Lympha-Flow(LF1200)?

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 Lympha-Flow(LF1200)?

The FDA product code for Lympha-Flow(LF1200) is IRP.

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

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.

View all 10 devices →

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.

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.