Device Classification Name |
Set, Tubing And Support, Ventilator (W Harness)
|
510(k) Number |
K903404 |
Device Name |
FLOCARE F |
Applicant |
FLOCARE MEDICAL |
992 EAGLE SCHOOL RD. |
SUITE 913 |
WAYNE,
PA
19087
|
|
Applicant Contact |
AL W KRAUS |
Correspondent |
FLOCARE MEDICAL |
992 EAGLE SCHOOL RD. |
SUITE 913 |
WAYNE,
PA
19087
|
|
Correspondent Contact |
AL W KRAUS |
Regulation Number | 868.5975
|
Classification Product Code |
|
Date Received | 07/31/1990 |
Decision Date | 09/25/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|