FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TREND ANALYZER
K Number: K761077
·
Decision Dec 28, 1976
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
86
Applicant Total
5
Review Days
39
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Basic Information
- Device Name
- TREND ANALYZER
- K Number
- K761077
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.2810
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Eldeco
- Date Received
- November 19, 1976
- Decision Date
- December 28, 1976
- Product Code
- DSF
- 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 |
|---|---|---|---|
| DSF | Recorder, Paper Chart | FDA class 1 | Cardiovascular |
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Other Clearances by Eldeco
| K Number | Device Name | ||
|---|---|---|---|
| K761074 | DYNAMIC RECORDER (DR-10) | Dec 28, 1976 | Substantially Equivalent |
| K761075 | SPORTS RECORDER (SR-10) | Dec 28, 1976 | Substantially Equivalent |
| K761076 | DEMODULATOR/CARDIOTACHOMETER | Dec 28, 1976 | Substantially Equivalent |
| K761073 | POCKET TRANSMITTER (PT-10) | Dec 28, 1976 | Substantially Equivalent |