510(k) K121480
K121480 is an FDA 510(k) premarket notification submitted by Spacelabs Healthcare for the device "ARIATELE TELEMETRY TRANSMITTER (96281)". The FDA issued a decision of Substantially Equivalent on June 6, 2012. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Spacelabs Healthcare has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 2012
- Date Received
- May 18, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type