510(k) K071164
K071164 is an FDA 510(k) premarket notification submitted by Amco International Manufacturing & Design, Inc. for the device "LIFE+CEL BATTERY". The FDA issued a decision of Substantially Equivalent on Dec 7, 2007. 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. Amco International Manufacturing & Design, Inc. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 7, 2007
- Date Received
- Apr 26, 2007
- Clearance Type
- Traditional
- 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
- 510(k)