The following data is part of a premarket notification filed by Baxter Healthcare Corproration with the FDA for Hillrom Heart And Respiration Rate Monitoring System Powered By Earlysense.
| Device ID | K223246 |
| 510k Number | K223246 |
| Device Name: | Hillrom Heart And Respiration Rate Monitoring System Powered By EarlySense |
| Classification | Monitor, Breathing Frequency |
| Applicant | Baxter Healthcare Corproration 1069 State Route 46 East Batesville, IN 47006 |
| Contact | Jigar Shah |
| Correspondent | Jigar Shah Baxter Healthcare Corproration 1069 State Route 46 East Batesville, IN 47006 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-10-20 |
| Decision Date | 2022-11-18 |