Device Classification Name |
monitor, esophageal motility, anorectal motility, and tube
|
510(k) Number |
K770785 |
Device Name |
MONITOR, RESPIRATORY, TWO-GAS, RDC |
Applicant |
RESEARCH DEVELOPMENT CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
RESEARCH DEVELOPMENT CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 05/02/1977 |
Decision Date | 05/20/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|