The following data is part of a premarket notification filed by American I.v. Products, Inc. with the FDA for Patient Controlled Analgesia (pca) Button Cable.
| Device ID | K120209 |
| 510k Number | K120209 |
| Device Name: | PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE |
| Classification | Accessories, Pump, Infusion |
| Applicant | AMERICAN I.V. PRODUCTS, INC. 7485 SHIPLEY AVE. Harmans, MD 21077 |
| Contact | Majdi Shomali |
| Correspondent | Majdi Shomali AMERICAN I.V. PRODUCTS, 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 | 2012-01-24 |
| Decision Date | 2012-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M745BC10969 | K120209 | 000 |
| M745BC10746 | K120209 | 000 |