FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WRITER, GEMINI-3
K Number: K781867
·
Decision Jan 5, 1979
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
86
Applicant Total
5
Review Days
63
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Basic Information
- Device Name
- WRITER, GEMINI-3
- K Number
- K781867
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.2810
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- C-V Monitors Corp.
- Date Received
- November 3, 1978
- Decision Date
- January 5, 1979
- 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 C-V Monitors Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K792099 | 50MM WRITER MODEL CVM 9529 | Oct 26, 1979 | Substantially Equivalent |
| K790004 | MONITOR SCOPES, MODELS 9502, 9503 | Feb 28, 1979 | Substantially Equivalent |
| K780572 | DCG PREAMPLIFIER MODULE | May 9, 1978 | Substantially Equivalent |
| K780571 | BLOOD PRESSURE MODULE | May 9, 1978 | Substantially Equivalent |