Device Classification Name |
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
|
510(k) Number |
K903745 |
Device Name |
THE HAYEK OSCILLATOR |
Applicant |
FLEXCO MEDICAL INSTRUMENTS |
KIRCHWEG 151, 8102 |
OBERENGSTRINGEN |
ZURICH, SWITZERLAND,
CH
|
|
Applicant Contact |
EDITH MULLER |
Correspondent |
FLEXCO MEDICAL INSTRUMENTS |
KIRCHWEG 151, 8102 |
OBERENGSTRINGEN |
ZURICH, SWITZERLAND,
CH
|
|
Correspondent Contact |
EDITH MULLER |
Regulation Number | 868.5935
|
Classification Product Code |
|
Date Received | 08/16/1990 |
Decision Date | 11/09/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|