The following data is part of a premarket notification filed by Mui Scientific with the FDA for Rapid Barostat Bag (rbb) Pump And Catheter.
| Device ID | K160287 |
| 510k Number | K160287 |
| Device Name: | Rapid Barostat Bag (RBB) Pump And Catheter |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | MUI SCIENTIFIC 145 TRADERS BLVD. EAST #33-34 Mississauga, CA L4z 3l3 |
| Contact | Tammy Mui |
| Correspondent | Tammy Mui MUI SCIENTIFIC 145 TRADERS BLVD. EAST #33-34 Mississauga, CA L4z 3l3 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-03 |
| Decision Date | 2017-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00678467505118 | K160287 | 000 |