Device Classification Name |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
|
510(k) Number |
K172959 |
Device Name |
PeraServer and PeraTrend |
Applicant |
PeraHealth, Inc. |
6302 Fairview Rd.,Suite 310 |
Charlotte,
NC
28210
|
|
Applicant Contact |
Joseph Beals |
Correspondent |
Biologics Consulting |
1555 Kingh Street, Suite 300 |
Alexandria,
VA
22314
|
|
Correspondent Contact |
Donna-Bea Tillman |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 09/26/2017 |
Decision Date | 05/01/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|