Device Classification Name |
Warmer, Infant Radiant
|
510(k) Number |
K910915 |
Device Name |
PATIENT WARMER MODEL 100C |
Applicant |
DEVELOPMED CORP. |
P.O. BOX 27342 |
HOUSTON,
TX
77227
|
|
Applicant Contact |
CHARLES BOYD |
Correspondent |
DEVELOPMED CORP. |
P.O. BOX 27342 |
HOUSTON,
TX
77227
|
|
Correspondent Contact |
CHARLES BOYD |
Regulation Number | 880.5130 |
Classification Product Code |
|
Date Received | 03/05/1991 |
Decision Date | 07/16/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|