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FDA 510(k)

PSA SERIES

K-Number: K123916 · 2013-04-09

ApplicantOsypka Medical, Inc.
Decision Date2013-04-09
Product CodeDTE
Advisory CommitteeCV
DecisionUnknown

Device Summary

PSA SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Osypka Medical, Inc.. It received FDA 510(k) clearance on 2013-04-09 under 510(k) number K123916. The device is classified under product code DTE. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the PSA SERIES?

PSA SERIES is a medical device that received FDA 510(k) clearance on 2013-04-09. The listed applicant is Osypka Medical, Inc.. The 510(k) number is K123916.

When did PSA SERIES receive FDA 510(k) clearance?

PSA SERIES received FDA 510(k) clearance on 2013-04-09, under 510(k) number K123916.

Who is the listed applicant for PSA SERIES?

The FDA 510(k) record lists Osypka Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PSA SERIES?

The FDA product code for PSA SERIES is DTE.

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Other records listing Osypka Medical, Inc. as applicant

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Related Devices (Code: DTE)

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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