Device Classification Name |
Monitor, Breathing Frequency
|
510(k) 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 |
Applicant |
Hill-Rom, Inc. |
1069 State Route 46 East |
Batesville,
IN
47006
|
|
Applicant Contact |
Jigar Shah |
Correspondent |
Hill-Rom, Inc. |
1069 State Route 46 East |
Batesville,
IN
47006
|
|
Correspondent Contact |
Jigar Shah |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 07/21/2020 |
Decision Date | 03/04/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|