Home / 510(k) Clearances / K900313

510(k) K900313

PERCUSSIONAIRE(R) VDR-3 IMV PERCUS/RESPIR 1250 MIN by Percussionaire Corp. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1990
Date Received
January 22, 1990
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 Percussionaire Corp.

  • K905234 — TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES (June 13, 1991)
  • K905235 — VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS (May 3, 1991)
  • K905236 — IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES (April 18, 1991)
  • K900315 — PERCUSSIONAIRE TXP TRANSPORTER/RESPIRATORS 750 MIN (October 26, 1990)
  • K900314 — PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN (October 26, 1990)
  • K896586 — RATE INCREASE FOR IPPB/IPV (January 9, 1990)
  • K895485 — BIRD (IPV) NONCONTINUOUS VENTILATORS (October 30, 1989)
  • K892886 — PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR (October 27, 1989)
  • K895486 — BIRD (VDR) SINUSOIDAL PERCUSSIONATORS (October 13, 1989)
  • K884832 — PERCUSSIONAIRE RESPIRATORS (MULTIPLE) (September 14, 1989)

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)