Device Classification Name |
Warmer, Infant Radiant
|
510(k) Number |
K853926 |
Device Name |
NEOCARE MODEL 800 INFANT RADIANT WARMER |
Applicant |
DRAEGER MEDICAL, INC. |
148 B. QUARRY RD. |
TELFORD,
PA
18969
|
|
Applicant Contact |
EDWARD T GRIFFITH |
Correspondent |
DRAEGER MEDICAL, INC. |
148 B. QUARRY RD. |
TELFORD,
PA
18969
|
|
Correspondent Contact |
EDWARD T GRIFFITH |
Regulation Number | 880.5130
|
Classification Product Code |
|
Date Received | 09/24/1985 |
Decision Date | 02/26/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|