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510(k) K010724

SOLA 700,SOLA 500, SOLA 300 by Drager Medizintechnik GmbH — Product Code FTD

K010724 is an FDA 510(k) premarket notification submitted by Drager Medizintechnik GmbH for the device "SOLA 700,SOLA 500, SOLA 300". The FDA issued a decision of Substantially Equivalent on June 7, 2001. The device falls under product code FTD (Lamp, Surgical), 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
June 7, 2001
Date Received
March 12, 2001
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Surgical
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)
  • K003067 — CALEO (December 13, 2000)
  • K984611 — DRAGER SOLA SERIES, MODELS 1000/700/500/300 (March 29, 1999)

Other clearances for product code FTD

  • K133425 — SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL (December 5, 2013)
  • K130513 — VOLISTA 400; VOLISTA 600 (May 8, 2013)
  • K123776 — POLARIS 100/200 (March 8, 2013)
  • K111020 — ATRICURE DISSECTOR (June 9, 2011)
  • K100234 — HM-LAMP II (July 8, 2010)
  • K100884 — STRYKER KNIFELIGHT (June 25, 2010)
  • K071180 — SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 (June 20, 2007)
  • K053364 — HALUX IRIS EXAMINATION AND SURGICAL LAMP (February 23, 2006)
  • K041681 — ATRICURE DISSECTOR (July 1, 2004)
  • K013242 — AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM (December 13, 2001)

FDA data resources