FDA 510(k) Applications for Medical Device:
Attachment, Breathing, Positive End Expiratory Pressure
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K090317 |
A PLUS MEDICAL |
5431 AVENIDA ENCINAS
| CARLSBAD |
CA |
92008 |
K110713 |
AIRWAYS DEVELOPMENT, LLC |
P.O. BOX 558
| CEDAR KNOLLS |
NJ |
07927 |
K160112 |
BESMED HEALTH BUSINESS CORP. |
NO.5, LANE 116, WU-KONG 2ND RD
| NEW TAIPEI CITY |
|
|
K982283 |
CARADYNE, LTD. |
6329 W. WATERVIEW CT.
| MCCORDSVILLE |
IN |
46055 |
K981415 |
CHEEN HOUNG ENT. CO. LTD. |
23 SAN DREEN ST., ALLEY 11,
| TAIPEI (SHULIN) |
|
23805 |
K092029 |
DRAEGER MEDICAL AG & CO. KG |
3135 Quarry Road
| Telford |
PA |
18969 |
K983920 |
ENGINEERED MEDICAL SYSTEMS |
8529 ZIONSVILLE RD.
| INDIANAPOLIS |
IN |
46268 |
K133957 |
GALEMED CORP. |
AMOY EXPORT PROCESSING ZONE, 39
| XIAMEN, FUJIAN |
|
361000 |
K963347 |
INSTRUMENTATION INDUSTRIES, INC. |
2990 INDUSTRIAL BLVD.
| BETHEL PARK |
PA |
15102 |
K050918 |
KOO AMERICAS, INC. |
1050-C NINE NORTH DRIVE
| ALPHARETTA |
GA |
30004 |
K961867 |
MEDICAL MARKETING CONCEPTS |
2310 YORK RD.
| ROANOKE |
VA |
24015 |
K081266 |
MERCURY ENTERPRIZES DBA MERCURY MEDICAL |
11300 49TH STREET NORTH
| CLEARWATER |
FL |
33762 |
K090710 |
MERCURY MEDICAL |
24301 WOODSAGE DRIVE
| BONITA SPRINGS |
FL |
34134 |
K070416 |
NEOFORCE GROUP, INC. |
35 COMMERCE DR.
| IVYLAND |
PA |
18974 |
K103833 |
NEOFORCE GROUP, INC. |
35 COMMERCE DR.
| IVYLAND |
PA |
18974 |
K962492 |
NIDEK MEDICAL PRODUCTS, INC. |
3949 VALLEY EAST INDUSTRIAL DR
| BIRMINGHAM |
AL |
35217 |
K112546 |
O-TWO MEDICAL TECHNOLOGIES, INC. |
7575 KIMBEL ST.
| MISSISSAUGA, ONTARIO |
|
L5S 1C8 |
K080256 |
PULMODYNE |
24301 WOODSAGE DRIVE
| BONITA SPRINGS |
FL |
33134-2958 |
K133210 |
S & T MEDICAL TECHNOLOGIES, INC. |
1954 KELLOGG AVENUE
| CARLSBAD |
CA |
92008 |
K122610 |
SEN MU TECHNOLOGY CO., LTD. |
NO. 15-2, LANE 26, MINCYUAN 1SR RD
| KAOHSIUNG CITY |
|
802 |
K001318 |
SIMS PORTEX, INC. |
10 BOWMAN DR.
| KEENE |
NH |
03431 |
K013884 |
VYGON S A |
45900 PARSIPPANY COURT
| TEMECULA |
CA |
92592 |
K955047 |
WESTMED INTL. |
3351 EAST HEMISPHERE LOOP
| TUCSON |
AZ |
85706 |
|
|