|
Device |
electrocardiograph |
Regulation Description |
Electrocardiograph. |
Product Code | DPS |
Regulation Number |
870.2340
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACME PORTABLE MACHINES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIOLOGS TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONTEC MEDICAL SYSTEMS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONTEC MEDICAL SYSTEMS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDAN INSTRUMENTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
FUKUDA DENSHI CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUKUDA DENSHI USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MITAC INTERNATIONAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MORTARA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MORTARA INSTRUMENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCHILLER |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SCHILLER AG |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN CAREWELL ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VALES & HILLS BIOMEDICAL TECH. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VECTRACOR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZOLL MANUFACTURING CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|