The following data is part of a premarket notification filed by American I.v. Products, Inc. with the FDA for Pulse Oximeter Adapter Cables.
| Device ID | K052544 |
| 510k Number | K052544 |
| Device Name: | PULSE OXIMETER ADAPTER CABLES |
| Classification | Oximeter |
| Applicant | AMERICAN I.V. PRODUCTS, INC. 7485 SHIPLEY AVE. Hanover, MD 21076 |
| Contact | Gregory Falk |
| Correspondent | Gregory Falk AMERICAN I.V. PRODUCTS, INC. 7485 SHIPLEY AVE. Hanover, MD 21076 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-15 |
| Decision Date | 2006-09-29 |
| Summary: | summary |