FDA 510(k) Applications for Medical Device:
Device, Sleep Assessment
| FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
| K181077 |
ActiGraph |
49 E Chase St
| Pensacola |
FL |
32502 |
| K231532 |
ActiGraph, LLC |
70 North Baylen Street, Suite 400
| Pensacola |
FL |
32504 |
| K233987 |
Arbor Medical Innovations, LLC |
168 S. Industrial Drive
| Saline |
MI |
48176 |
| K981969 |
BRAEBON MEDICAL CORP. |
63 ACKLAM TERRACE
| KANATA |
|
K2K 2H7 |
| K040986 |
CADWELL LABORATORIES, INC. |
909 NORTH KELLOGG ST.
| KENNEWICK |
WA |
99336 |
| K040932 |
CADWELL LABORATORIES, INC. |
909 NORTH KELLOGG ST.
| KENNEWICK |
WA |
99336 |
| K132764 |
CAMNTECH, LTD |
UPPER PENDRILL COURT
| PAPWORTH EVERARD, CAMBRIDGESHIRE |
|
CB233UY |
| K151784 |
CONDOR INSTRUMENTS LTDA. - EPP |
AVENIDA BRIGADEIRO LUIS ANTONIO, 551, CJ 124
| SAO PAULO |
|
01318-000 |
| K961817 |
KOVEN TECHNOLOGY, INC. |
300 BROOKES DR.
| ST. LOUIS |
MO |
63042 |
| K965079 |
NEURIM PHARMACEUTICALS, LTD. |
12300 TWINBROOK PARKWAY, SUIT5
| ROCKVILLE |
MD |
20852 |
| K233618 |
Oxehealth Limited |
Magdalen Centre North
| Oxford |
|
OX4 4GA |
| K243513 |
PneumoWave, Ltd |
Suites 3 and 4, Second Floor, Maxim 3
| Eurocentral |
|
ML1 4WQ |
| K003499 |
RESPIRONICS, INC. |
1001 MURRY RIDGE LN.
| MURRYSVILLE |
PA |
15668 |
| K111514 |
SLEEP PERFORMANCE D.B.A. FATIGUE SCIENCE |
5405 ALTON PARKWAY
| IRVINE |
CA |
92604 |
|
|