510(k) K833430
K833430 is an FDA 510(k) premarket notification submitted by Medical Intelcom, Inc. for the device "BLOOD GAS EXPERSYSTEM 8700". The FDA issued a decision of Substantially Equivalent on February 10, 1984. The device falls under product code LLE (Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease), a Class III device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 1984
- Date Received
- October 5, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease
- Device Class
- Class III
- Regulation Number
- Review Panel
- NE
- Submission Type