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FDA 510(k)

UniPulse

K-Number: K182905 · 2018-12-14

ApplicantSeaward Group
Decision Date2018-12-14
Product CodeDRL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UniPulse is the device name listed in this FDA 510(k) record. The listed applicant is Seaward Group. It received FDA 510(k) clearance on 2018-12-14 under 510(k) number K182905. The device is classified under product code DRL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UniPulse?

UniPulse is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is Seaward Group. The 510(k) number is K182905.

When did UniPulse receive FDA 510(k) clearance?

UniPulse received FDA 510(k) clearance on 2018-12-14, under 510(k) number K182905.

Who is the listed applicant for UniPulse?

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

What is the FDA product code for UniPulse?

The FDA product code for UniPulse is DRL.

Related Devices (Code: DRL)

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.

K190437Delta 3300Netech Corporation

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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