FDA 510(k)
Substantially Equivalent
🇺🇸 United States
MODEL ELI-100/ST ELECTROCARDIOGRAPH
K Number: K895232
·
Decision Dec 13, 1989
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
51
Review Days
114
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MODEL ELI-100/ST ELECTROCARDIOGRAPH
- K Number
- K895232
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Mortara Instrument, Inc.
- Date Received
- August 21, 1989
- Decision Date
- December 13, 1989
- 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.
| K Number | Device Name | ||
|---|---|---|---|
| K182297 | Surveyor S2 | Jan 24, 2019 | Substantially Equivalent |
| K173765 | Surveyor Patient Monitor | Sep 4, 2018 | Substantially Equivalent |
| 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 |