510(k) K832131
K832131 is an FDA 510(k) premarket notification submitted by Litton Medical Electronics for the device "SERVOMED CENTRAL STATION SMV 206". The FDA issued a decision of Substantially Equivalent on Nov 16, 1983. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Litton Medical Electronics has 37 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 16, 1983
- Date Received
- Jul 1, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type
- 510(k)