Device Classification Name |
analyzer, ion, hydrogen-ion (ph), blood-phase, indwelling
|
510(k) Number |
K970906 |
Device Name |
PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR |
Applicant |
DIAMETRICS MEDICAL, LTD. |
SHORT STREET |
HIGH WYCOMBE, BUCKINGHAMSHIRE,
GB
HP11 2QH
|
|
Applicant Contact |
JAN WALTERS |
Correspondent |
DIAMETRICS MEDICAL, LTD. |
SHORT STREET |
HIGH WYCOMBE, BUCKINGHAMSHIRE,
GB
HP11 2QH
|
|
Correspondent Contact |
JAN WALTERS |
Regulation Number | 868.1170
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/12/1997 |
Decision Date | 09/23/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|