510(k) K911348
K911348 is an FDA 510(k) premarket notification submitted by Bruel & Kjaer for the device "RIGID ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on June 21, 1991. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Bruel & Kjaer has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 1991
- Date Received
- March 27, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Nuclear Magnetic Resonance Imaging
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type