The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Hospira Vital Signs Wireless Monitoring System.
Device ID | K090610 |
510k Number | K090610 |
Device Name: | HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM |
Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
Applicant | HOSPIRA, INC. 275 NORTH FIELD DR. D-389, BLDG., H2 Lake Forest, IL 60045 |
Contact | Yuliya Matlin |
Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
Product Code | DRG |
CFR Regulation Number | 870.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2009-03-06 |
Decision Date | 2009-03-13 |
Summary: | summary |