The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Suresigns Vs3, Suresigns Vs4.
Device ID | K133961 |
510k Number | K133961 |
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 | 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-12-24 |
Decision Date | 2014-06-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838054127 | K133961 | 000 |