FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
G.E. TELEMETRY MONITORING
K Number: K761259
·
Decision Dec 21, 1976
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
19
Applicant Total
254
Review Days
6
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Basic Information
- Device Name
- G.E. TELEMETRY MONITORING
- K Number
- K761259
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1855
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- General Electric Co.
- Date Received
- December 15, 1976
- Decision Date
- December 21, 1976
- Product Code
- GYE
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GYE | Encephalogram Telemetry System | FDA class 2 | Neurology |
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