Device Classification Name |
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
|
510(k) Number |
K861861 |
Device Name |
515A NEO-TRAK NEONATAL MONITOR |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
JOSEPH P LENZEN |
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH |
WALLINGFORD,
CT
06492
|
|
Correspondent Contact |
JOSEPH P LENZEN |
Regulation Number | 868.2500
|
Classification Product Code |
|
Date Received | 05/14/1986 |
Decision Date | 07/10/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|