510(k) K800931
K800931 is an FDA 510(k) premarket notification submitted by R2 Corp. for the device "R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122". The FDA issued a decision of Substantially Equivalent on May 23, 1980. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. R2 Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 1980
- Date Received
- April 21, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cable, Transducer And Electrode, Patient, (Including Connector)
- Device Class
- Class II
- Regulation Number
- 870.2900
- Review Panel
- CV
- Submission Type