FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIO EXPRESS 100 HOLTER SCANNER
K Number: K840622
·
Decision Jul 2, 1984
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
54
Review Days
139
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
- CARDIO EXPRESS 100 HOLTER SCANNER
- K Number
- K840622
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Del Mar Avionics
- Date Received
- February 14, 1984
- Decision Date
- July 2, 1984
- Product Code
- DSI
- 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DSI), ordered by most recent decision date.
BodyGuardian Remote Monitoring System (BGRMS v3.0)
FDA 510(k)
FDA Class 2
·Cardiovascular
MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
FDA 510(k)
FDA Class 2
·Cardiovascular
Zio AT® device (A100A1001)
FDA 510(k)
FDA Class 2
·Cardiovascular
MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
FDA 510(k)
FDA Class 2
·Cardiovascular
SmartCardia 7L Platform
FDA 510(k)
FDA Class 2
·Cardiovascular
Unified Arrhythmia Diagnostic System PocketECG IV
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Del Mar Avionics
| K Number | Device Name | ||
|---|---|---|---|
| K990027 | OMNICORDER, MODEL 464 | Feb 9, 1999 | Substantially Equivalent |
| K971696 | SENTINEL RECORDER, MODELS 471/472 | Dec 30, 1997 | Substantially Equivalent |
| K963174 | HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) | Mar 13, 1997 | Substantially Equivalent |
| K950020 | HOLTER PACERCORDER(R) | Aug 17, 1995 | Substantially Equivalent |
| K942653 | HOLTER SSR DIGICORDER(TM) | May 10, 1995 | Substantially Equivalent |
| K922221 | SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM | Apr 21, 1993 | Substantially Equivalent |
| K896862 | MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM | Apr 18, 1990 | Substantially Equivalent |
| K895793 | MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION | Feb 13, 1990 | Substantially Equivalent |
| K894543 | MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER | Feb 8, 1990 | Substantially Equivalent |
| K891148 | MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM | May 11, 1989 | Substantially Equivalent |