The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Suresigns Vsi Vital Signs Monitor.
Device ID | K110803 |
510k Number | K110803 |
Device Name: | SURESIGNS VSI VITAL SIGNS MONITOR |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
Contact | Mary Kruitwagen |
Correspondent | Mary Kruitwagen PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
Product Code | DXN |
Subsequent Product Code | DQA |
Subsequent Product Code | FLL |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-23 |
Decision Date | 2011-05-20 |
Summary: | summary |