FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Tempus Pro Patient Monitor
K Number: K170567
·
Decision Jul 6, 2017
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
424
Applicant Total
11
Review Days
129
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Basic Information
- Device Name
- Tempus Pro Patient Monitor
- K Number
- K170567
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Remote Diagnostic Technologies , Ltd.
- Date Received
- February 27, 2017
- Decision Date
- July 6, 2017
- Product Code
- MHX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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Other Clearances by Remote Diagnostic Technologies , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K173768 | Tempus Pro Patient Monitor | Jan 10, 2018 | Substantially Equivalent |
| K133973 | TEMPUS PRO WITH ENHANCED FEATURES | Aug 14, 2014 | Substantially Equivalent |
| K134014 | TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) | Aug 12, 2014 | Substantially Equivalent |
| K133988 | TEMPUS PRO EXTENDED FEATURES | May 16, 2014 | Substantially Equivalent |
| K130773 | TEMPUS PRO PATIENT MONITOR | Jun 5, 2013 | Substantially Equivalent |
| K113105 | TEMPUSIC PATIENT MONITOR | Dec 15, 2011 | Substantially Equivalent |
| K101264 | TEMPUS IC PROFESSIONAL PATIENT MONITOR | May 11, 2010 | Substantially Equivalent |
| K082718 | TEMPUSIC PATIENT MONITOR | Oct 10, 2008 | Substantially Equivalent |
| K033410 | TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 | Mar 5, 2004 | Substantially Equivalent |
| K010436 | TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 | May 14, 2001 | Substantially Equivalent |