Device Classification Name |
Monitor, Breathing Frequency
|
510(k) Number |
K850504 |
Device Name |
COROMETRICS 500 INFANT 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 | 868.2375
|
Classification Product Code |
|
Date Received | 02/08/1985 |
Decision Date | 06/24/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|