Device Classification Name |
pump, infusion
|
510(k) Number |
K071545 |
Device Name |
Z-800 VOLUMETRIC INFUSION PUMP |
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 | 06/06/2007 |
Decision Date | 10/31/2007 |
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
|
Recalls |
CDRH Recalls
|
|
|