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 |