Device Classification Name |
Accessory, Assisted Reproduction
|
510(k) Number |
K121566 |
Device Name |
PLANER BT37 INCUBATOR |
Applicant |
PLANER PLC |
15696 OAKSTAND ROAD |
POWAY,
CA
92064 -3389
|
|
Applicant Contact |
ERIC GRUFF |
Correspondent |
PLANER PLC |
15696 OAKSTAND ROAD |
POWAY,
CA
92064 -3389
|
|
Correspondent Contact |
ERIC GRUFF |
Regulation Number | 884.6120
|
Classification Product Code |
|
Date Received | 05/29/2012 |
Decision Date | 11/29/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|