The following data is part of a premarket notification filed by Bio Compression Systems, Inc. with the FDA for Model Sc-3004-dl Sequential Circulator, Model Sc-3004fc-dl Sequenstial Circulator, Model Sc-2008-dl Sequential Circulator, Model Sc-3008-dl Sequential Circulator.
| Device ID | K142640 |
| 510k Number | K142640 |
| Device Name: | Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator |
| Classification | Sleeve, Limb, Compressible |
| Applicant | BIO COMPRESSION SYSTEMS, INC. 120 WEST COMMERCIAL AVE. Moonachie, NJ 07074 |
| Contact | Barbara Whitman |
| Correspondent | Barbara Whitman BIO COMPRESSION SYSTEMS, INC. 120 WEST COMMERCIAL AVE. Moonachie, NJ 07074 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-17 |
| Decision Date | 2014-11-06 |
| Summary: | summary |