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
|
|
|