Device Classification Name |
monitor, breathing frequency
|
510(k) Number |
K790304 |
Device Name |
PREAMPLIFIER MODULE, EKG RESPIRATION |
Applicant |
ABBOTT MEDICAL ELECTRONICS CO. |
HOUSTON,
TX
|
|
Correspondent |
ABBOTT MEDICAL ELECTRONICS CO. |
HOUSTON,
TX
|
|
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 02/13/1979 |
Decision Date | 02/27/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|