Device Classification Name |
monitor, breathing frequency
|
510(k) Number |
K962781 |
Device Name |
COROMETRICS MODEL 510 AND 511 MONITOR |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
MARIA V FOUTS |
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH |
WALLINGFORD,
CT
06492
|
|
Correspondent Contact |
MARIA V FOUTS |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 07/17/1996 |
Decision Date | 03/06/1997 |
Decision |
SE SUBJECT TO TRACKING REG
(ST) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|