Home / 510(k) Clearances / K984611

510(k) K984611

DRAGER SOLA SERIES, MODELS 1000/700/500/300 by Drager Medizintechnik GmbH — Product Code FSY

K984611 is an FDA 510(k) premarket notification submitted by Drager Medizintechnik GmbH for the device "DRAGER SOLA SERIES, MODELS 1000/700/500/300". The FDA issued a decision of Substantially Equivalent on March 29, 1999. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Drager Medizintechnik GmbH has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1999
Date Received
December 29, 1998
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Ceiling Mounted
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Drager Medizintechnik GmbH

  • K023289 — OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072 (January 15, 2003)
  • K010793 — OXYLOG 1000, MODEL 2M86840 (December 20, 2001)
  • K012177 — VENTVIEW, MODEL 8414095 (September 4, 2001)
  • K003068 — SAVINA (June 25, 2001)
  • K010093 — NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 (June 14, 2001)
  • K010724 — SOLA 700,SOLA 500, SOLA 300 (June 7, 2001)
  • K003067 — CALEO (December 13, 2000)

Other clearances for product code FSY

  • K142984 — Leo Minor (October 29, 2014)
  • K142076 — CLAVEGUARD FREEDOM SURGICAL LIGHT (September 30, 2014)
  • K140812 — MI-750 PROCEDURAL/MINOR SURGICAL LIGHT (August 7, 2014)
  • K132551 — ZF 720 (June 30, 2014)
  • K140930 — VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES (June 9, 2014)
  • K140460 — MACH LED 2SC (April 3, 2014)
  • K140461 — MACH LED 2MC (April 3, 2014)
  • K132747 — VISUM BLADE LED SURGICAL LIGHTING SYSTEM (December 30, 2013)
  • K132307 — VIDA LED SURGICAL LIGHTING SYSTEM (November 5, 2013)
  • K131893 — AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (October 30, 2013)

FDA data resources