Remunity Pump for Remodulin (treprostinil) Injection
K-Number: K202690 · 2020-12-30
ApplicantDeka Research and Development
Decision Date2020-12-30
Product CodeQJY
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Remunity Pump for Remodulin (treprostinil) Injection is a medical device manufactured by Deka Research and Development. It received FDA 510(k) clearance on 2020-12-30 under approval number K202690. The device is classified under product code QJY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Remunity Pump for Remodulin (treprostinil) Injection?
Remunity Pump for Remodulin (treprostinil) Injection is a medical device that received FDA 510(k) clearance on 2020-12-30. It is manufactured by Deka Research and Development. The 510(k) number is K202690.
When was Remunity Pump for Remodulin (treprostinil) Injection approved by the FDA?
Remunity Pump for Remodulin (treprostinil) Injection received FDA 510(k) clearance on 2020-12-30, under approval number K202690.
What company makes Remunity Pump for Remodulin (treprostinil) Injection?
Remunity Pump for Remodulin (treprostinil) Injection is manufactured by Deka Research and Development.
What is the FDA product code for Remunity Pump for Remodulin (treprostinil) Injection?
The FDA product code for Remunity Pump for Remodulin (treprostinil) Injection is QJY.
Other Devices by Deka Research and Development
Related Devices (Code: QJY)
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.