Device Classification Name |
Unit, Neonatal Phototherapy
|
510(k) Number |
K954611 |
Device Name |
DRAGER PT4000 PHOTOTHERAPY SYSTEM |
Applicant |
DRAGER, INC. |
4101-100 PLEASANT VALLEY RD. |
CHANTILLY,
VA
22021
|
|
Applicant Contact |
HARALD KNEUER |
Correspondent |
DRAGER, INC. |
4101-100 PLEASANT VALLEY RD. |
CHANTILLY,
VA
22021
|
|
Correspondent Contact |
HARALD KNEUER |
Regulation Number | 880.5700
|
Classification Product Code |
|
Date Received | 10/04/1995 |
Decision Date | 12/01/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|