510(k) K840521
K840521 is an FDA 510(k) premarket notification submitted by Litton Medical Electronics for the device "SERVOMED DIGITAL DISPLAY MODULE". The FDA issued a decision of Substantially Equivalent on June 1, 1984. 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 at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 1984
- Date Received
- February 7, 1984
- 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