Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K031883 |
Device Name |
LYRA NASAL MASK |
Applicant |
SENSORMEDICS CORP. |
22705 SAVI RANCH PKWY. |
YORBA LINDA,
CA
92887 -4645
|
|
Applicant Contact |
PAUL L KITTINGER |
Correspondent |
SENSORMEDICS CORP. |
22705 SAVI RANCH PKWY. |
YORBA LINDA,
CA
92887 -4645
|
|
Correspondent Contact |
PAUL L KITTINGER |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 06/18/2003 |
Decision Date | 08/25/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|