FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW
K Number: K984089
·
Decision Feb 16, 1999
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
395
Applicant Total
7
Review Days
92
Basic Information
- Device Name
- ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW
- K Number
- K984089
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ZYMED MEDICAL INSTRUMENTATION
- Date Received
- November 16, 1998
- Decision Date
- February 16, 1999
- 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 |
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Other Clearances by ZYMED MEDICAL INSTRUMENTATION
| K Number | Device Name | ||
|---|---|---|---|
| K002004 | ZYBIT | Sep 21, 2000 | Substantially Equivalent |
| K992197 | MODIFICATION TO ZYMED HOLTER 2000 | Jul 28, 1999 | Substantially Equivalent |
| K990170 | HOLTER 2000 | Apr 13, 1999 | Substantially Equivalent |
| K955015 | ZYMED HOLTER SCANNER MODEL 2010 | Mar 18, 1996 | Substantially Equivalent |
| K951370 | ZYMED TELEMETRY SYSTEM; MODEL T8010 | Oct 6, 1995 | Substantially Equivalent |
| K930894 | MULTITRAK-PLUS | Nov 1, 1993 | Substantially Equivalent |