The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Transpac Iii Disposable Straight Pressure Transducer And Kit.
| Device ID | K061573 |
| 510k Number | K061573 |
| Device Name: | TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | HOSPIRA, INC. 275 NORTH FIELD DR. Lake Forest, IL 60045 |
| Contact | Thomas Kozma |
| Correspondent | Thomas Kozma HOSPIRA, INC. 275 NORTH FIELD DR. Lake Forest, IL 60045 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-07 |
| Decision Date | 2006-09-19 |
| Summary: | summary |