Device Classification Name |
monitor, carbon-dioxide, cutaneous
|
510(k) Number |
K980756 |
Device Name |
COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
RICHARD CEHOVSKY |
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH |
WALLINGFORD,
CT
06492
|
|
Correspondent Contact |
RICHARD CEHOVSKY |
Regulation Number | 868.2480
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/27/1998 |
Decision Date | 11/05/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|