The following data is part of a premarket notification filed by Phillips Medical Systems with the FDA for Suresigns Vs3, Suresigns Vs4.
Device ID | K151761 |
510k Number | K151761 |
Device Name: | SureSigns VS3, SureSigns VS4 |
Classification | Alarm, Blood-pressure |
Applicant | PHILLIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 |
Contact | Greg Li |
Correspondent | Greg Li PHILLIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 |
Product Code | DSJ |
Subsequent Product Code | CCK |
Subsequent Product Code | DSK |
Subsequent Product Code | FLL |
CFR Regulation Number | 870.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-06-29 |
Decision Date | 2015-09-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838028890 | K151761 | 000 |