FDA 510(k)
Substantially Equivalent
🇺🇸 United States
MORTARA INSTRUMENT MODEL ECG PREVU
K Number: K920377
·
Decision Apr 28, 1992
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
51
Review Days
90
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Basic Information
- Device Name
- MORTARA INSTRUMENT MODEL ECG PREVU
- K Number
- K920377
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mortara Instrument, Inc.
- Date Received
- January 29, 1992
- Decision Date
- April 28, 1992
- Product Code
- LOS
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LOS), ordered by most recent decision date.
Other Clearances by Mortara Instrument, Inc.
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|---|---|---|---|
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| 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 |