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 |