Home / 510(k) Clearances / K970839

510(k) K970839

SERVO VENTILATOR 300A by Siemens Elema AB — Product Code CBK

Clearance Details

Decision
ST ()
Decision Date
October 14, 1997
Date Received
March 7, 1997
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 Siemens Elema AB

  • K023354 — COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E (September 5, 2003)
  • K010923 — KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E (January 23, 2002)
  • K010925 — SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E (December 18, 2001)
  • K002137 — CATHCOR DESKTOP (October 5, 2000)
  • K001315 — MODIFICATION TO KION ANESTHESIA SYSTEM (May 26, 2000)
  • K960010 — SERVO VENTILATOR 300 COMPUTER INTERFACE (October 25, 1996)
  • K960168 — SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990 (October 25, 1996)
  • K872278 — SIEMENS O2-AIR MIXER 965 (September 3, 1987)
  • K871354 — SERVO VENTILATOR 900 C/D (July 21, 1987)
  • K871829 — SIEMENS DRY AIR COMPRESSOR (June 15, 1987)

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)