The following data is part of a premarket notification filed by Mui Scientific with the FDA for Pressurized Infusion Pump.
| Device ID | K122294 |
| 510k Number | K122294 |
| Device Name: | PRESSURIZED INFUSION PUMP |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | MUI SCIENTIFIC 145 TRADERS BLVD. EAST, # 34 Mississauga, CA L4z 3l3 |
| Contact | Tammy Mui |
| Correspondent | Tammy Mui MUI SCIENTIFIC 145 TRADERS BLVD. EAST, # 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 | 2012-07-31 |
| Decision Date | 2012-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00678467003430 | K122294 | 000 |
| 00678467002105 | K122294 | 000 |
| 00678467000101 | K122294 | 000 |
| 00678467507099 | K122294 | 000 |
| 00678467507105 | K122294 | 000 |
| 00678467004147 | K122294 | 000 |
| 00678467504425 | K122294 | 000 |
| 00678467000019 | K122294 | 000 |
| 00678467000026 | K122294 | 000 |
| 00678467000033 | K122294 | 000 |
| 00678467000040 | K122294 | 000 |
| 00678467000132 | K122294 | 000 |