Unity Subcutaneous Infusion System for Remodulin
K-Number: K191313 · 2020-02-21
Device Summary
Frequently Asked Questions
What is the Unity Subcutaneous Infusion System for Remodulin?
Unity Subcutaneous Infusion System for Remodulin is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is DEKA Research & Development. The 510(k) number is K191313.
When did Unity Subcutaneous Infusion System for Remodulin receive FDA 510(k) clearance?
Unity Subcutaneous Infusion System for Remodulin received FDA 510(k) clearance on 2020-02-21, under 510(k) number K191313.
Who is the listed applicant for Unity Subcutaneous Infusion System for Remodulin?
The FDA 510(k) record lists DEKA Research & Development as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Unity Subcutaneous Infusion System for Remodulin?
The FDA product code for Unity Subcutaneous Infusion System for Remodulin is QJY.
Other records listing DEKA Research & Development 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.
Related Devices (Code: QJY)
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.