|
Device |
flowmeter, blood, cardiovascular |
Product Code | DPW |
Regulation Number |
870.2100
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
COOK VASCULAR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DELTEX MEDICAL LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
EM-TEC GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FLOSONICS MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FLOSONICS MEDICAL (R/A 1929803 ONTARIO CORP.) |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HUNTLEIGH HEALTHCARE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KOVEN TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LASER ASSOCIATED SCIENCES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDI-STIM ASA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MOOR INSTRUMENTS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OR-NIM MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PERIMED AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REMINGTON MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
1. K211589 VascuChek Kit, VascuChek Transceiver, VascuChek Su ...
|
2. K212065 VascuChek Kit, VascuChek Transceiver, VascuChek Cl ...
|
RFPI |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNOVIS MICRO COMPANIES ALLIANCE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRANSONIC SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VASAMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|