The following data is part of a premarket notification filed by Bio Compression Systems, Inc. with the FDA for Model Multi-flo Ic-1545-kt/-f Intermittent Circulator.
| Device ID | K061857 |
| 510k Number | K061857 |
| Device Name: | MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR |
| Classification | Sleeve, Limb, Compressible |
| Applicant | BIO COMPRESSION SYSTEMS, INC. P.O. BOX 470218 Broadview Heights, OH 44141 |
| Contact | James Jochen Rogers |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-06-30 |
| Decision Date | 2006-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812311022059 | K061857 | 000 |
| 00812311021182 | K061857 | 000 |
| 00812311021175 | K061857 | 000 |
| 00812311021168 | K061857 | 000 |
| 00812311021151 | K061857 | 000 |
| 00812311020673 | K061857 | 000 |
| 00812311020666 | K061857 | 000 |