Home / 510(k) Clearances / K911348

510(k) K911348

RIGID ENDOSCOPE by Bruel & Kjaer — Product Code LNH

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

Other clearances by Bruel & Kjaer

  • K925484 — CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308 (June 22, 1993)
  • K914295 — ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED (April 10, 1992)
  • K905198 — DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535 (August 28, 1991)

Other clearances for product code LNH

  • K254277 — Embrace Neonatal MRI System (March 13, 2026)
  • K253413 — LiverMultiScan (v6.0) (March 9, 2026)
  • K251901 — Magnifico Open (100009900) (March 5, 2026)
  • K253648 — Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/Q (February 23, 2026)
  • K260265 — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (February 23, 2026)
  • K253780 — SIGNA™ Bolt (February 6, 2026)
  • K253779 — SIGNA™ Sprint Select (February 5, 2026)
  • K253499 — Ascent3T Neonatal Magnetic Resonance Imaging System (January 26, 2026)
  • K252379 — AIR Recon DL (December 23, 2025)
  • K252838 — MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETO (December 19, 2025)