| Device Classification Name |
Scale, Patient
|
| 510(k) Number |
K870888 |
| Device Name |
WARM WEIGH MODEL N-10 INFANT SCALE |
| Applicant |
| Air-Shields, Inc. |
| 330 Jacksonville Rd. |
|
Hatboro,
PA
19040
|
|
| Applicant Contact |
CHRISTIAN ANDREASEN |
| Correspondent |
| Air-Shields, Inc. |
| 330 Jacksonville Rd. |
|
Hatboro,
PA
19040
|
|
| Correspondent Contact |
CHRISTIAN ANDREASEN |
| Regulation Number | 880.2720 |
| Classification Product Code |
|
| Date Received | 03/05/1987 |
| Decision Date | 03/17/1987 |
| 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
|
|
|