The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Earlyvue Vs30.
Device ID | K190624 |
510k Number | K190624 |
Device Name: | EarlyVue VS30 |
Classification | Alarm, Blood-pressure |
Applicant | Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard Strasse 2 Boeblingen, DE 71034 |
Contact | Greg Li |
Correspondent | Greg Li Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard Strasse 2 Boeblingen, DE 71034 |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-03-11 |
Decision Date | 2019-10-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838091412 | K190624 | 000 |