Device Classification Name |
Bronchoscope (Flexible Or Rigid)
|
510(k) Number |
K131028 |
Device Name |
PENTAX VIDEO BRONCHOSCOPES (EB FAMILY) |
Applicant |
PENTAX MEDICAL COMPANY |
3 PARAGON DRIVE |
MONTVALE,
NJ
07645
|
|
Applicant Contact |
KRISHNA GOVINDARAJAN |
Correspondent |
PENTAX MEDICAL COMPANY |
3 PARAGON DRIVE |
MONTVALE,
NJ
07645
|
|
Correspondent Contact |
KRISHNA GOVINDARAJAN |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 04/12/2013 |
Decision Date | 04/10/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|