510(k) K082077
K082077 is an FDA 510(k) premarket notification submitted by Corscience GmbH & Co. KG for the device "BT3/6, BT12". The FDA issued a decision of Substantially Equivalent on September 2, 2008. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Corscience GmbH & Co. KG has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 2008
- Date Received
- July 23, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Transmitters And Receivers, Electrocardiograph, Telephone
- Device Class
- Class II
- Regulation Number
- 870.2920
- Review Panel
- CV
- Submission Type