Device Classification Name |
incubator, neonatal transport
|
510(k) Number |
K001019 |
Device Name |
TI500 GLOBE-TROTTER TRANSPORT SYSTEM |
Applicant |
HILL-ROM AIR-SHIELDS |
330 JACKSONVILLE RD. |
HATBORO,
PA
19040
|
|
Applicant Contact |
JAMES G CARPENTER |
Correspondent |
HILL-ROM AIR-SHIELDS |
330 JACKSONVILLE RD. |
HATBORO,
PA
19040
|
|
Correspondent Contact |
JAMES G CARPENTER |
Regulation Number | 880.5410
|
Classification Product Code |
|
Date Received | 03/30/2000 |
Decision Date | 04/27/2000 |
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
|
|
|