Device Classification Name |
monitor, breathing frequency
|
510(k) Number |
K842048 |
Device Name |
SUN-ONE |
Applicant |
ENSUN MEDICAL PRODUCTS, INC. |
10011 WEST GULF BANK |
HOUSTON ,
TX
77040 -
|
|
Applicant Contact |
ALLEN KEARNS |
Correspondent |
ENSUN MEDICAL PRODUCTS, INC. |
10011 WEST GULF BANK |
HOUSTON ,
TX
77040 -
|
|
Correspondent Contact |
ALLEN KEARNS |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 05/22/1984 |
Decision Date | 11/01/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|