510(k) K040663
K040663 is an FDA 510(k) premarket notification submitted by Molex, Inc. for the device "TELENABLE EMS SYSTEM". The FDA issued a decision of Substantially Equivalent on Jun 30, 2004. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 30, 2004
- Date Received
- Mar 12, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device Class
- Class II
- Regulation Number
- 870.2910
- Review Panel
- CV
- Submission Type
- 510(k)