The following data is part of a premarket notification filed by Delphi Medical Systems with the FDA for Delphi Infusion Pump/ Delphi Administration Set Model Iv-01000/ Model Iv-02xxxx (where X Is Any Number Between 0-9).
| Device ID | K093332 |
| 510k Number | K093332 |
| Device Name: | DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9) |
| Classification | Pump, Infusion |
| Applicant | DELPHI MEDICAL SYSTEMS 5725 DELPHI DR Troy, MI 48098 |
| Contact | Gilbert Roque Jr. |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-10-26 |
| Decision Date | 2009-12-09 |
| Summary: | summary |