Home / 510(k) Clearances / K060705

510(k) K060705

CARINA HOME by Draeger Medical B.V. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2006
Date Received
March 16, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Draeger Medical B.V.

  • K121886 — SAVINA 300 SAVINA 300, COUNTRY VARIANTS (August 8, 2014)
  • K133886 — PERSEUS A500 (June 20, 2014)
  • K121999 — GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE (February 28, 2013)
  • K103035 — SMARTPILOT VIEW MODEL MK04500 (March 28, 2012)
  • K082600 — OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 57 (November 26, 2008)
  • K042607 — PRIMUS US (November 26, 2004)
  • K042419 — FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM (October 8, 2004)
  • K042276 — D-VAPOR (September 23, 2004)
  • K042086 — FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM (August 31, 2004)
  • K041622 — MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM (July 8, 2004)

Other clearances for product code CBK

  • K251888 — VPAP Pediatric Face Mask (March 12, 2026)
  • K232365 — Vivo 45 LS (December 19, 2025)
  • K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits (September 10, 2025)
  • K243767 — SV600, SV800 Ventilator (August 28, 2025)
  • K251133 — AVEA disposable expiratory filter/water trap (11790) (May 8, 2025)
  • K243394 — AF531 Oro-Nasal SE Face Mask (December 30, 2024)
  • K233486 — 731 Series Ventilator (December 13, 2024)
  • K223120 — Ventoux VC2; Ventoux VC3 (December 2, 2024)
  • K241135 — RESPOND(R) Ventilator (November 13, 2024)
  • K241943 — Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 (August 28, 2024)