Device Classification Name |
monitor, breathing frequency
|
510(k) Number |
K873791 |
Device Name |
MODEL 500E INFANT MONITORING SYSTEM |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
J. P LENZEN |
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH |
WALLINGFORD,
CT
06492
|
|
Correspondent Contact |
J. P LENZEN |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 09/17/1987 |
Decision Date | 11/23/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|