510(k) K811758
K811758 is an FDA 510(k) premarket notification submitted by Powers Medical Systmes for the device "ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR". The FDA issued a decision of Substantially Equivalent on August 3, 1981. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Powers Medical Systmes has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 1981
- Date Received
- June 22, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transmitters And Receivers, Electrocardiograph, Telephone
- Device Class
- Class II
- Regulation Number
- 870.2920
- Review Panel
- CV
- Submission Type