Device Classification Name |
Monitor, Apnea, Facility Use
|
510(k) Number |
K991087 |
Device Name |
HANNAH WIRELESS VITAL SIGNS MONITOR |
Applicant |
ILIFE SYSTEMS, INC. |
5910 N. CENTRAL EXPRESSWAY |
SUITE 1775 |
DALLAS,
TX
75206
|
|
Applicant Contact |
JOSHUA A ADLER |
Correspondent |
ILIFE SYSTEMS, INC. |
5910 N. CENTRAL EXPRESSWAY |
SUITE 1775 |
DALLAS,
TX
75206
|
|
Correspondent Contact |
JOSHUA A ADLER |
Regulation Number | 868.2377
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/31/1999 |
Decision Date | 01/12/2000 |
Decision |
SE SUBJECT TO TRACKING REG
(ST) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|