Device Classification Name |
ventilatory effort recorder
|
510(k) Number |
K983572 |
Device Name |
SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 |
Applicant |
HEALTHDYNE TECHNOLOGIES, INC. |
1255 KENNESTONE CIR. |
MARIETTA,
GA
30066
|
|
Applicant Contact |
BETSY CORTELLONI |
Correspondent |
HEALTHDYNE TECHNOLOGIES, INC. |
1255 KENNESTONE CIR. |
MARIETTA,
GA
30066
|
|
Correspondent Contact |
BETSY CORTELLONI |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 10/13/1998 |
Decision Date | 03/19/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|