FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECG REVIEW STATION
K Number: K942685
·
Decision Aug 12, 1997
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
77
Applicant Total
51
Review Days
1162
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Basic Information
- Device Name
- ECG REVIEW STATION
- K Number
- K942685
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mortara Instrument, Inc.
- Date Received
- June 7, 1994
- Decision Date
- August 12, 1997
- Product Code
- DXJ
- 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 |
|---|---|---|---|
| DXJ | Display, Cathode-Ray Tube, Medical | FDA class 2 | Cardiovascular |
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Other Clearances by Mortara Instrument, Inc.
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|---|---|---|---|
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| K161517 | Mortara Surveyor Patient Monitor | Jan 11, 2017 | Substantially Equivalent |
| K161465 | CardioConfirm | Sep 3, 2016 | Substantially Equivalent |
| K160685 | Surveyor S4 Mobile Monitor | Aug 4, 2016 | Substantially Equivalent |
| K152626 | H3+ Holter Recorder | Feb 26, 2016 | Substantially Equivalent |
| K152944 | Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems | Jan 6, 2016 | Substantially Equivalent |
| K141020 | SURVEYOR S4 MOBILE MONITOR | Dec 3, 2014 | Substantially Equivalent |
| K133989 | AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM | Nov 25, 2014 | Substantially Equivalent |
| K141811 | MORTARA MONITORING WAVEFORM VIEWER | Nov 19, 2014 | Substantially Equivalent |