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510(k) K970785

SIMS HYPERINFLATION BAG SYSTEM by Sims — Product Code NHK

K970785 is an FDA 510(k) premarket notification submitted by Sims for the device "SIMS HYPERINFLATION BAG SYSTEM". The FDA issued a decision of Substantially Equivalent on June 13, 1997. The device falls under product code NHK (Resuscitator, Manual, Non Self-Inflating), a Class II device regulated under 21 CFR 868.5905. Sims has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1997
Date Received
March 4, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resuscitator, Manual, Non Self-Inflating
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of compressed breathing gas is required to inflate the bag.

Other clearances by Sims

  • K972283 — SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT (September 17, 1997)

Other clearances for product code NHK

  • K092687 — VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER (November 23, 2009)
  • K020281 — MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM (February 11, 2002)
  • K013308 — VENTLAB HYPERINFLATION BAG SYSTEM (December 20, 2001)
  • K001714 — MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 (November 3, 2000)
  • K952214 — SIMS INTERTECH HYPERINFLATION BAG SYSTEM (June 8, 1995)
  • K942571 — HYPER-INFLATION BAG (June 10, 1994)
  • K940255 — HYPERINFLATION BAG SYSTEM (February 17, 1994)
  • K894612 — INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM (September 8, 1989)
  • K813317 — DISP. HYPERINFLATION BAG SYSTEM (March 12, 1982)

FDA data resources