510(k) K844180
K844180 is an FDA 510(k) premarket notification submitted by Ellis Pharmaceutical Consulting, Inc. for the device "THE MCP-70-SE SYSTEM". The FDA issued a decision of Substantially Equivalent on February 1, 1985. The device falls under product code KQA (Device, Beam Limiting, X-Ray, Therapeutic), a Class II device regulated under 21 CFR 892.5900. Ellis Pharmaceutical Consulting, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1985
- Date Received
- October 26, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Beam Limiting, X-Ray, Therapeutic
- Device Class
- Class II
- Regulation Number
- 892.5900
- Review Panel
- RA
- Submission Type