Device Classification Name |
Set, Tubing And Support, Ventilator (W Harness)
|
510(k) Number |
K823479 |
Device Name |
MODUFLEX NEONATAL VENTILATOR SET |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1875 EYE ST. NW STE. 625 |
WASHINGTON,
DC
20006
|
|
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1875 EYE ST. NW STE. 625 |
WASHINGTON,
DC
20006
|
|
Regulation Number | 868.5975
|
Classification Product Code |
|
Date Received | 11/23/1982 |
Decision Date | 12/15/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|