510(k) K771748
K771748 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "INTRA ORAL X-RAY CONES". The FDA issued a decision of Substantially Equivalent on September 28, 1977. The device falls under product code EAH (Cone, Radiographic, Lead-Lined), a Class I device regulated under 21 CFR 872.1850. General Electric Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 1977
- Date Received
- September 15, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cone, Radiographic, Lead-Lined
- Device Class
- Class I
- Regulation Number
- 872.1850
- Review Panel
- RA
- Submission Type