Device Classification Name |
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
|
510(k) Number |
K820417 |
Device Name |
#506 PORT. VITAL FUNCTIONS NEONATAL MON |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 02/16/1982 |
Decision Date | 03/04/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|