The following data is part of a premarket notification filed by Hill-rom, Inc. with the FDA for Hill-rom Heart And Respiration Rate Monitoring System: Single Sensor, Hill-rom Heart And Respiration Rate Monitoring System: Sensor Packs, Hill-rom Heart And Respiration Rate Monitoring System: Sensor Activation.
| Device ID | K202018 |
| 510k Number | K202018 |
| Device Name: | Hill-Rom Heart And Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart And Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart And Respiration Rate Monitoring System: Sensor Activation |
| Classification | Monitor, Breathing Frequency |
| Applicant | Hill-Rom, Inc. 1069 State Route 46 East Batesville, IN 47006 |
| Contact | Jigar Shah |
| Correspondent | Jigar Shah 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 | Yes |
| Date Received | 2020-07-21 |
| Decision Date | 2021-03-04 |