FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TELEMETRY, BIOMEDICAL
K Number: K790109
·
Decision Mar 16, 1979
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
190
Applicant Total
8
Review Days
58
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Basic Information
- Device Name
- TELEMETRY, BIOMEDICAL
- K Number
- K790109
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2910
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Lkc Technologies, Inc.
- Date Received
- January 17, 1979
- Decision Date
- March 16, 1979
- Product Code
- DRG
- 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 |
|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | FDA class 2 | Cardiovascular |
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|---|---|---|---|
| K142567 | RETeval Visual Electrodiagnostic Device | May 19, 2015 | Substantially Equivalent |
| K914163 | SCOPTOPIC SENSITIVITY TEST-1[SST-1] | Oct 25, 1991 | Substantially Equivalent |
| K913962 | ANOMALOSCOPE QUADRANT TEST-6 | Oct 23, 1991 | Substantially Equivalent |
| K875026 | ANOMALOSCOPE PLATE TEST - 5 [APT-5] | Feb 5, 1988 | Substantially Equivalent |
| K874336 | PATTERN DISCRIMINATION PERIMETER | Jan 12, 1988 | Substantially Equivalent |
| K820414 | UNIVERSAL TESTING & ANALYSIS SYSTEMS | Mar 4, 1982 | Substantially Equivalent |
| K760199 | ELECTRORETINOGRAPH | Aug 4, 1976 | Substantially Equivalent |