Device Classification Name |
catheter, intravascular, therapeutic, long-term greater than 30 days
|
510(k) Number |
K171931 |
Device Name |
Celerity ECG Cable Accessory Pack |
Applicant |
Medcomp (Medical Components, Inc.) |
1499 Delp Dr. |
Harleysville,
PA
19438
|
|
Applicant Contact |
Colton Muraira |
Correspondent |
Medcomp (Medical Components, Inc.) |
1499 Delp Dr. |
Harleysville,
PA
19438
|
|
Correspondent Contact |
Colton Muraira |
Regulation Number | 880.5970
|
Classification Product Code |
|
Date Received | 06/28/2017 |
Decision Date | 10/26/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|