The following data is part of a premarket notification filed by Hill-rom Inc. with the FDA for Hill-rom Vitals Monitoring System Powered By Earlysense: Sensor Packs (different #), Hill-rom Vitals Monitoring System Powered By Earlysense: Sensor Activation.
Device ID | K180079 |
510k Number | K180079 |
Device Name: | Hill-Rom Vitals Monitoring System Powered By EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System Powered By EarlySense: Sensor Activation |
Classification | Monitor, Breathing Frequency |
Applicant | Hill-Rom Inc. 1069 State Route 46 East Batesville, IN 47006 |
Contact | Sarah Marie Fitzgerald |
Correspondent | Sarah Marie Fitzgerald Hill-Rom Inc. 1069 State Route 46 East Batesville, IN 47006 |
Product Code | BZQ |
CFR Regulation Number | 868.2375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-01-10 |
Decision Date | 2018-05-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
17290016169239 | K180079 | 000 |
00887761985155 | K180079 | 000 |
00887761975705 | K180079 | 000 |