The following data is part of a premarket notification filed by Bruel & Kjaer with the FDA for Rigid Endoscope.
| Device ID | K911348 |
| 510k Number | K911348 |
| Device Name: | RIGID ENDOSCOPE |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | BRUEL & KJAER 18 NAERUM HOVEDGODE Naerum 2850, DK |
| Contact | Aage Ruby |
| Correspondent | Aage Ruby BRUEL & KJAER 18 NAERUM HOVEDGODE Naerum 2850, DK |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-27 |
| Decision Date | 1991-06-21 |