Device Classification Name |
unit, neonatal phototherapy
|
510(k) Number |
K810953 |
Device Name |
MODEL 533 PHOTOTHERAPY UNIT |
Applicant |
NARCO AIR-SHIELDS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
NARCO AIR-SHIELDS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 880.5700
|
Classification Product Code |
|
Date Received | 04/07/1981 |
Decision Date | 04/23/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|