510(k) K833000
K833000 is an FDA 510(k) premarket notification submitted by Litton Medical Electronics for the device "I-CHANNEL RECORDER". The FDA issued a decision of Substantially Equivalent on Jun 1, 1984. The device falls under product code DSF (Recorder, Paper Chart), a Class I device regulated under 21 CFR 870.2810. Litton Medical Electronics has 37 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 1, 1984
- Date Received
- Aug 18, 1983
- 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