510(k) K781867
K781867 is an FDA 510(k) premarket notification submitted by C-V Monitors Corp. for the device "WRITER, GEMINI-3". The FDA issued a decision of Substantially Equivalent on Jan 5, 1979. The device falls under product code DSF (Recorder, Paper Chart), a Class I device regulated under 21 CFR 870.2810. C-V Monitors Corp. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 5, 1979
- Date Received
- Nov 3, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Recorder, Paper Chart
- Device Class
- Class I
- Regulation Number
- 870.2810
- Review Panel
- CV
- Submission Type
- 510(k) Exempt