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 |