Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K823081 |
Device Name |
M2100 ANTEPARTUM FETAL MONITOR |
Applicant |
HUNTLEIGH TECHNOLOGY, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
HUNTLEIGH TECHNOLOGY, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 10/19/1982 |
Decision Date | 01/26/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|