510(k) K202018
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 by
Hill-Rom, Inc.
— Product Code BZQ
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 2021
- Date Received
- July 21, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Breathing Frequency
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type