The following data is part of a premarket notification filed by Mui Scientific with the FDA for Sphincter Of Oddi Manometric (som) System.
| Device ID | K120524 |
| 510k Number | K120524 |
| Device Name: | SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | MUI SCIENTIFIC 145 TRADERS BLVD. EAST UNIT 33-34 Mississauga, CA L4z 3l3 |
| Contact | Tammy Mui |
| Correspondent | Tammy Mui MUI SCIENTIFIC 145 TRADERS BLVD. EAST UNIT 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 | 2012-02-22 |
| Decision Date | 2012-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00678467004161 | K120524 | 000 |
| 00678467000071 | K120524 | 000 |