FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZYMED HOLTER SCANNER MODEL 2010
K Number: K930806
·
Decision Apr 25, 1994
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
13
Review Days
433
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Basic Information
- Device Name
- ZYMED HOLTER SCANNER MODEL 2010
- K Number
- K930806
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Agilent Technologies
- Date Received
- February 16, 1993
- Decision Date
- April 25, 1994
- Product Code
- DQK
- 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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Other Clearances by Agilent Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K010949 | 2010 PLUS HOLTER FOR WINDOWS | Sep 28, 2001 | Substantially Equivalent |
| K003940 | 2010 PLUS HOLTER FOR WINDOWS | Feb 8, 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 |
| 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 |