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510(k) K915564

SPIROS by Life Support Products, Inc. — Product Code BTL

K915564 is an FDA 510(k) premarket notification submitted by Life Support Products, Inc. for the device "SPIROS". The FDA issued a decision of Substantially Equivalent on January 30, 1992. The device falls under product code BTL (Ventilator, Emergency, Powered (Resuscitator)), a Class II device regulated under 21 CFR 868.5925. Life Support Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1992
Date Received
December 12, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Powered (Resuscitator)
Device Class
Class II
Regulation Number
868.5925
Review Panel
AN
Submission Type

Other clearances by Life Support Products, Inc.

  • K941870 — LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100 (January 9, 1995)
  • K941871 — LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100 (January 9, 1995)
  • K940934 — LIFE VAC (May 3, 1994)
  • K936187 — LSPI PRESSURE REGULATOR (January 27, 1994)
  • K932200 — LSPI AUTOMATIC VENTILATOR (November 24, 1993)
  • K932199 — LSPI AUTOMATIC VENTILATOR, MODEL AV3000 (November 24, 1993)
  • K922819 — INFANT DISPOSABLE BAG MASK RESUSCITATOR (November 24, 1993)
  • K922691 — LSP (MODEL 554) BAG MASK RESUSCITATOR (November 24, 1993)
  • K921553 — LSPI INFANT BAG MASK (October 19, 1992)
  • K921107 — AUTOVAC (September 17, 1992)

Other clearances for product code BTL

  • K242769 — VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) (April 4, 2025)
  • K221634 — Oxymag - Transport and Emergency Ventilator (May 24, 2023)
  • K202219 — VORTRAN GO2VENT with PEEP Valve (February 11, 2021)
  • K193191 — MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag (November 20, 2020)
  • K182956 — Puffin Lite Infant Resuscitation System (January 18, 2019)
  • K173373 — SafeT T-Piece Resuscitator (November 16, 2018)
  • K161420 — MOVES SLC (June 6, 2017)
  • K162968 — VORTRAN GO2VENT (April 10, 2017)
  • K141595 — O-TWO E700,O-TWO E600,O-TWO E500 (March 16, 2015)
  • K142096 — T-PIECE RESUSCITATOR (October 17, 2014)

FDA data resources