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510(k) K040712

AIR SAFETY HEPA, MODEL 3500 by Air Safety, Ltd. — Product Code MOD

K040712 is an FDA 510(k) premarket notification submitted by Air Safety, Ltd. for the device "AIR SAFETY HEPA, MODEL 3500". The FDA issued a decision of Substantially Equivalent on June 3, 2004. The device falls under product code MOD (Accessory To Continuous Ventilator (Respirator)), a Class II device regulated under 21 CFR 868.5895. Air Safety, Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2004
Date Received
March 18, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory To Continuous Ventilator (Respirator)
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Air Safety, Ltd.

  • K051712 — MODEL 2800 PFT FILTER (September 1, 2005)
  • K050953 — AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE (June 29, 2005)
  • K033008 — AIR SAFETY HEPA AND NON-HEPA FILTERS (May 13, 2004)

Other clearances for product code MOD

  • K260051 — CorVision® (91-205-Z0014) (May 12, 2026)
  • K242485 — EveryWare (May 20, 2025)
  • K161411 — Care Cycle Connect Application (February 17, 2017)
  • K091461 — BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE (August 14, 2009)
  • K052751 — VENTLINK SYSTEM (December 23, 2005)
  • K052244 — IISIS, VERSION 1.0 (October 13, 2005)
  • K022062 — IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 (May 6, 2003)
  • K010401 — TRI-PLEX ADAPTER (October 30, 2002)
  • K011861 — BERNOULLI VENTILATOR MANAGEMENT SYSTEM (November 6, 2001)
  • K963633 — VENTNET; CENTRAL MONITORING STATION (December 16, 1996)

FDA data resources