510(k) K083229
K083229 is an FDA 510(k) premarket notification submitted by Ld Technology, LLC for the device "E.S TECK ( ELECTRO SENSOR TECK)". The FDA issued a decision of Substantially Equivalent on February 23, 2009. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Ld Technology, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2009
- Date Received
- November 3, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type