The following data is part of a premarket notification filed by Terumo Bct, Inc.. with the FDA for Spectra Optia Apheresis System, Spectra Optia Single-needle Connector, Spectra Optia System Software.
| Device ID | K131744 |
| 510k Number | K131744 |
| Device Name: | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE |
| Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | TERUMO BCT, INC.. 10811 WEST COLLINS AVE. Lakewood, CO 80215 |
| Contact | Tina O'brien |
| Correspondent | Tina O'brien TERUMO BCT, INC.. 10811 WEST COLLINS AVE. Lakewood, CO 80215 |
| Product Code | LKN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-13 |
| Decision Date | 2013-08-08 |
| Summary: | summary |