FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
H-SCRIBE
K Number: K004017
·
Decision Jun 11, 2001
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
31
Applicant Total
51
Review Days
166
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Basic Information
- Device Name
- H-SCRIBE
- K Number
- K004017
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mortara Instrument, Inc.
- Date Received
- December 27, 2000
- Decision Date
- June 11, 2001
- Product Code
- MLO
- 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 |
|---|---|---|---|
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | FDA class 2 | Cardiovascular |
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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 |