Device Classification Name |
Monitor, Breathing Frequency
|
510(k) Number |
K862747 |
Device Name |
8800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORS |
Applicant |
ATLAS RESEARCHES LTD. |
P.O.B. 271 |
HOD-HASHARON 45102 |
ISRAEL,
IL
|
|
Applicant Contact |
ATLAS |
Correspondent |
ATLAS RESEARCHES LTD. |
P.O.B. 271 |
HOD-HASHARON 45102 |
ISRAEL,
IL
|
|
Correspondent Contact |
ATLAS |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 07/21/1986 |
Decision Date | 08/05/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|