FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
2010 PLUS HOLTER FOR WINDOWS
K Number: K003940
·
Decision Feb 8, 2001
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
31
Applicant Total
13
Review Days
49
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
- 2010 PLUS HOLTER FOR WINDOWS
- K Number
- K003940
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Agilent Technologies
- Date Received
- December 21, 2000
- Decision Date
- February 8, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MLO), ordered by most recent decision date.
Philips Holter Analysis System
FDA 510(k)
FDA Class 2
·Cardiovascular
Frontier X Plus
FDA 510(k)
FDA Class 2
·Cardiovascular
RX-1 Rhythm Express Remote Cardiac Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
CER-S
FDA 510(k)
FDA Class 2
·Cardiovascular
Faros Mobile
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDIOSPY ECG HOLTER SYSTEMS
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Agilent Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K010949 | 2010 PLUS HOLTER FOR WINDOWS | Sep 28, 2001 | Substantially Equivalent |
| K003763 | 2010 PLUS HOLTER FOR WINDOWS | Jan 5, 2001 | Substantially Equivalent |
| K001308 | MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW | May 17, 2000 | Substantially Equivalent |
| K990093 | ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW | May 11, 1999 | Substantially Equivalent |
| K980186 | ZYMED TELEMETRY SYSTEM | Oct 7, 1998 | Substantially Equivalent |
| K942781 | DIGITAL HOLTER RECORDER | Jan 24, 1995 | Substantially Equivalent |
| K930806 | ZYMED HOLTER SCANNER MODEL 2010 | Apr 25, 1994 | Substantially Equivalent |
| K924672 | ZYMED TELEMETRY MONITOR MODEL T8010 (PRELIMINARY) | Dec 15, 1992 | Substantially Equivalent |
| K895208 | ZYMED MODEL 1610 | Dec 12, 1989 | Substantially Equivalent |
| K841083 | QUIKPAGE ARRHYTHMIA REPORT GENERATOR | Feb 7, 1985 | Substantially Equivalent |