Device Classification Name |
Pump, Infusion
|
510(k) Number |
K100705 |
Device Name |
ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 |
Applicant |
ZYNO MEDICAL LLC |
395 TOTTEN POND RD. SUITE 201 |
WALTHAM,
MA
02451
|
|
Applicant Contact |
CHAOYOUNG LEE |
Correspondent |
ZYNO MEDICAL LLC |
395 TOTTEN POND RD. SUITE 201 |
WALTHAM,
MA
02451
|
|
Correspondent Contact |
CHAOYOUNG LEE |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 03/12/2010 |
Decision Date | 07/08/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|