The following data is part of a premarket notification filed by American I.v. Products, Inc. with the FDA for Ecg Cables, Trunk And Patient Lead Wires.
| Device ID | K070232 |
| 510k Number | K070232 |
| Device Name: | ECG CABLES, TRUNK AND PATIENT LEAD WIRES |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | AMERICAN I.V. PRODUCTS, INC. 7485 SHIPLEY AVE. Harmans, MD 21077 |
| Contact | John Taylor |
| Correspondent | John Taylor AMERICAN I.V. PRODUCTS, INC. 7485 SHIPLEY AVE. Harmans, MD 21077 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-24 |
| Decision Date | 2007-03-27 |
| Summary: | summary |