510(k) K921906
K921906 is an FDA 510(k) premarket notification submitted by Harris Mfg. Co. for the device "HARRIS MODEL 2000". The FDA issued a decision of Substantially Equivalent on November 2, 1992. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Harris Mfg. Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 1992
- Date Received
- April 21, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Multi Format, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2040
- Review Panel
- RA
- Submission Type