Home / 510(k) Clearances / K980642

510(k) K980642

EVITA 4 (8411900) by Drager, Inc. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1998
Date Received
February 19, 1998
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 Drager, Inc.

  • K992608 — ATC OPTION FOR EVITA 2 DURA AND EVITA 4 (August 24, 1999)
  • K984577 — DRAGER OXYLOG 2000 (January 22, 1999)
  • K983219 — NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900 (December 7, 1998)
  • K982789 — MEDICAL AIR COMPRESSOR, MODEL # 8413419 (October 29, 1998)
  • K974176 — BABYLOG 8000 PLUS (June 17, 1998)
  • K971198 — BABYTHERM 8004 BABYTHERM 8010 (October 3, 1997)
  • K970165 — EVITA 2 DURA (August 26, 1997)
  • K954204 — DRAGER INCUBATOR 8000 IC (April 25, 1997)
  • K961687 — EVITA 4 (December 13, 1996)
  • K950853 — OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS (November 5, 1996)

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)