The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Suresigns Vs3; Suresigns Vs4.
Device ID | K163649 |
510k Number | K163649 |
Device Name: | SureSigns VS3; SureSigns VS4 |
Classification | Alarm, Blood-pressure |
Applicant | Philips Medical Systems 3000 Minuteman Rd. Andover, MA 01810 |
Contact | Greg Li |
Correspondent | Greg Li Philips Medical Systems 3000 Minuteman Rd. Andover, MA 01810 |
Product Code | DSJ |
Subsequent Product Code | CCK |
Subsequent Product Code | DQA |
Subsequent Product Code | DSA |
Subsequent Product Code | DSK |
Subsequent Product Code | DXN |
Subsequent Product Code | FLL |
CFR Regulation Number | 870.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-12-23 |
Decision Date | 2017-03-31 |
Summary: | summary |