510(k) K810254
K810254 is an FDA 510(k) premarket notification submitted by Machlett Laboratories, Inc. for the device "1.5` FOCAL SPOT RESOLUTION PATTERN". The FDA issued a decision of Substantially Equivalent on February 19, 1981. The device falls under product code IXF (Test-Pattern, Radiographic), a Class I device regulated under 21 CFR 892.1940. Machlett Laboratories, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 1981
- Date Received
- January 30, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test-Pattern, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1940
- Review Panel
- RA
- Submission Type