FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTERVAL TIMER MODEL V4295
K Number: K790203
·
Decision Mar 2, 1979
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
23
Applicant Total
9
Review Days
31
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Basic Information
- Device Name
- INTERVAL TIMER MODEL V4295
- K Number
- K790203
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2050
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Electronics For Medicine, Inc.
- Date Received
- January 30, 1979
- Decision Date
- March 2, 1979
- Product Code
- DRR
- 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 |
|---|---|---|---|
| DRR | Amplifier And Signal Conditioner, Biopotential | FDA class 2 | Cardiovascular |
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Other Clearances by Electronics For Medicine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K830791 | UNIVERSAL MEDDARS SYSTEM | Jun 22, 1983 | Substantially Equivalent |
| K830795 | CABINET FOR MULTIPLE FUNCTION BLOCKS | May 18, 1983 | Substantially Equivalent |
| K792528 | RESPIRATION/APNEA AMPLIFIER MODEL 3105 | Feb 21, 1980 | Substantially Equivalent |
| K791006 | SMART BILECTRODES | Jun 11, 1979 | Substantially Equivalent |
| K790198 | MONITOR PLUG-IN MODEL M1106 ECG | Mar 6, 1979 | Substantially Equivalent |
| K790185 | MODEL V 4207 INTEGRATING PLUG-IN | Feb 16, 1979 | Substantially Equivalent |
| K780107 | ANALYZER-PLUG-IN, CO2 MODEL M 3104 | Jan 30, 1978 | Substantially Equivalent |
| K770366 | ISOLATED ELECTROCARDIOGRAPH MODEL 1207 | Mar 1, 1977 | Substantially Equivalent |