FDA 510(k)

Phadia Prime

K-Number: K151029 · 2016-01-19

Decision Date2016-01-19

Product CodeDHB

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

Phadia Prime is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2016-01-19 under 510(k) number K151029. The device is classified under product code DHB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Phadia Prime?

Phadia Prime is a medical device that received FDA 510(k) clearance on 2016-01-19. The listed applicant is Phadia AB. The 510(k) number is K151029.

When did Phadia Prime receive FDA 510(k) clearance?

Phadia Prime received FDA 510(k) clearance on 2016-01-19, under 510(k) number K151029.

Who is the listed applicant for Phadia Prime?

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

What is the FDA product code for Phadia Prime?

The FDA product code for Phadia Prime is DHB.

Other records listing Phadia AB as applicant

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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.