The following data is part of a premarket notification filed by Harvard Clinical Technology with the FDA for Harvard 1 Syringe Pump/harvard 1 With Pca Syringe Pump.
| Device ID | K033054 |
| 510k Number | K033054 |
| Device Name: | HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP |
| Classification | Pump, Infusion, Pca |
| Applicant | HARVARD CLINICAL TECHNOLOGY 22 PLEASANT ST. South Natick, MA 01760 |
| Contact | Eric J Flachbart |
| Correspondent | Susan A Gill UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2003-12-16 |
| Summary: | summary |