Device Classification Name |
ventilatory effort recorder
|
510(k) Number |
K042745 |
Device Name |
LIFESCREEN APNEA |
Applicant |
DEL MAR REYNOLDS MEDICAL, INC. |
377 ROUTE 17 S |
HASBROUCK HEIGHTS,
NJ
07604
|
|
Applicant Contact |
GEORGE MYERS |
Correspondent |
DEL MAR REYNOLDS MEDICAL, INC. |
377 ROUTE 17 S |
HASBROUCK HEIGHTS,
NJ
07604
|
|
Correspondent Contact |
GEORGE MYERS |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 10/04/2004 |
Decision Date | 01/19/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|