510(k) K920862
K920862 is an FDA 510(k) premarket notification submitted by B C Medical , Ltd. for the device "BCM-400C". The FDA issued a decision of Substantially Equivalent on September 30, 1992. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. B C Medical , Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 1992
- Date Received
- February 25, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Angiographic
- Device Class
- Class II
- Regulation Number
- 892.1600
- Review Panel
- RA
- Submission Type