510(k) K812400
K812400 is an FDA 510(k) premarket notification submitted by Omnimedical for the device "OMNIMEDICAL QUAD I". The FDA issued a decision of Substantially Equivalent on October 2, 1981. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Omnimedical has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 1981
- Date Received
- August 20, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomography, Computed
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type