Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K002722 |
Device Name |
DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505 |
Applicant |
JAWON MEDICAL CO., LTD. |
7F JEONG JU BLDG. |
SEOCHO-DONG. SEOCHO-KU |
SEOUL,
KR
1451-38
|
|
Applicant Contact |
WON-HEE PARK |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
2600 NW LAKE RD. |
CAMAS,
WA
98607 -9526
|
|
Correspondent Contact |
ROBERT BOONSTRA |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 08/31/2000 |
Decision Date | 09/11/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|