Device Classification Name |
monitor, physiological, patient (without arrhythmia detection or alarms)
|
510(k) Number |
K134014 |
Device Name |
TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) |
Applicant |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
THE OLD COACH HOUSE, THE AV. |
FARLEIGH WALLOP, BASINGSTOKE |
hampshire,
GB
rg25 2ht
|
|
Applicant Contact |
leigh cornock |
Correspondent |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
THE OLD COACH HOUSE, THE AV. |
FARLEIGH WALLOP, BASINGSTOKE |
hampshire,
GB
rg25 2ht
|
|
Correspondent Contact |
leigh cornock |
Regulation Number | 870.2300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/30/2013 |
Decision Date | 08/12/2014 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|