The following data is part of a premarket notification filed by Sigma Intl. with the FDA for Spectrum And Spectrum With Master Drug Library.
| Device ID | K042121 |
| 510k Number | K042121 |
| Device Name: | SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY |
| Classification | Pump, Infusion |
| Applicant | SIGMA INTL. 711 PARK AVE. Medina, NY 14103 -0756 |
| Contact | Charles L Martina |
| Correspondent | Derwyn Reuber INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-08-06 |
| Decision Date | 2004-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00085412091570 | K042121 | 000 |