510(k) K770338
K770338 is an FDA 510(k) premarket notification submitted by Litton Medical Systems for the device "X-RAY CONTROL & X-RAY HV GENERATOR". The FDA issued a decision of Substantially Equivalent on March 1, 1977. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Litton Medical Systems has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 1977
- Date Received
- February 18, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, High-Voltage, X-Ray, Diagnostic
- Device Class
- Class I
- Regulation Number
- 892.1700
- Review Panel
- RA
- Submission Type