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 |