510(k) K120253
K120253 is an FDA 510(k) premarket notification submitted by Elcam Medical Acal for the device "ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)". The FDA issued a decision of Substantially Equivalent on July 16, 2012. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Elcam Medical Acal has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 2012
- Date Received
- January 27, 2012
- 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