Home / 510(k) Clearances / K832418

510(k) K832418

OHIO TEMPERATURE SIMULATOR by Airco/Ohio Medical Products — Product Code FMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
July 22, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Incubator, Neonatal
Device Class
Class II
Regulation Number
880.5400
Review Panel
HO
Submission Type

Other clearances by Airco/Ohio Medical Products

  • K833459 — COAXIAL VOL. VENTILATOR CIRCUIT (January 10, 1984)
  • K833452 — OHIO GMS ABSORBER (November 29, 1983)
  • K832565 — OHIO 5400 VOLUME MONITOR (September 1, 1983)
  • K832185 — OHIO MODEL 922 SPIROMETER (August 12, 1983)
  • K830446 — OXYGEN MONITOR OHIO 5100 (March 24, 1983)
  • K822456 — OHIO V5A ANESTHESIA VENTILATOR (September 21, 1982)
  • K813476 — OHIO VOLUME INCENTIVE SPIROMETER (December 31, 1981)
  • K812879 — OHIO NON-REUSABLE TRACHEAL TUBE MURPHY (November 24, 1981)
  • K812880 — OHIO NON-REUSABLE TRACHEAL TUBE MAJILL (November 24, 1981)
  • K811413 — DABC NONCONDUCTIVE PEDIAT. ANESTH. CIR (June 2, 1981)

Other clearances for product code FMZ

  • K251619 — Babyleo TN500 (February 13, 2026)
  • K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (October 22, 2025)
  • K243437 — mOm Essential Incubator (ME1) (August 14, 2025)
  • K213553 — Giraffe Incubator Carestation CS1 (March 2, 2022)
  • K190494 — Infant Incubator (November 25, 2019)
  • K182859 — Babyleo TN500 (February 22, 2019)
  • K182977 — Isolette 8000 Plus (November 21, 2018)
  • K172154 — Isolette 8000 plus (April 19, 2018)
  • K162821 — Babyleo TN500 (June 23, 2017)
  • K152814 — Giraffe OmniBed Carestation CS1 (March 17, 2016)