The following data is part of a premarket notification filed by American I.v. Products, Inc Dba Aiv, Inc with the FDA for Smart Label, Propofol.
| Device ID | K142333 |
| 510k Number | K142333 |
| Device Name: | SMART LABEL, PROPOFOL |
| Classification | Accessories, Pump, Infusion |
| Applicant | AMERICAN I.V. PRODUCTS, INC Dba AIV, INC 7485 SHIPLEY AVE Harmans, MD 21077 |
| Contact | Shannon Houchen |
| Correspondent | Shannon Houchen AMERICAN I.V. PRODUCTS, INC Dba AIV, INC 7485 SHIPLEY AVE Harmans, MD 21077 |
| Product Code | MRZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-21 |
| Decision Date | 2014-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M745BX12812 | K142333 | 000 |