Delphi Infusion Pump/ Delphi Administration Set Model IV-01000/ Model IV-02XXXX (Where X Is Any Number Between 0-9)
FDA 510(k) K093332 · Delphi Medical Systems
510(k) numberK093332
Submission
- Device name
- Delphi Infusion Pump/ Delphi Administration Set Model IV-01000/ Model IV-02XXXX (Where X Is Any Number Between 0-9)
- Applicant
- Delphi Medical Systems
Troy, MI, US - Received
- October 26, 2009
- Decision date
- December 9, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| 510(k) | Device | Decision |
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| K073242 | Portable Oxygen Concentrator, Model RS-00400CAW · Traditional | 01/03/2008SE |
Questions and answers
When was Delphi Infusion Pump/ Delphi Administration Set Model IV-01000/ Model IV-02XXXX (Where X Is Any Number Between 0-9) cleared by the FDA?
Delphi Infusion Pump/ Delphi Administration Set Model IV-01000/ Model IV-02XXXX (Where X Is Any Number Between 0-9) (K093332) received a 510(k) decision of Substantially Equivalent on December 9, 2009, 44 days after the submission was received.
What is the product code of K093332?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.