FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGITAL HOLTER RECORDER
K Number: K942781
·
Decision Jan 24, 1995
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
13
Review Days
225
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Basic Information
- Device Name
- DIGITAL HOLTER RECORDER
- K Number
- K942781
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Agilent Technologies
- Date Received
- June 13, 1994
- Decision Date
- January 24, 1995
- Product Code
- DSH
- 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | FDA class 2 | Cardiovascular |
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Other Clearances by Agilent Technologies
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|---|---|---|---|
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| K003763 | 2010 PLUS HOLTER FOR WINDOWS | Jan 5, 2001 | Substantially Equivalent |
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| K990093 | ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW | May 11, 1999 | Substantially Equivalent |
| K980186 | ZYMED TELEMETRY SYSTEM | Oct 7, 1998 | 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 |