Home / 510(k) Clearances / K895782

510(k) K895782

NEONATAL INCUBATOR (ACCESSORY) by Air-Shields Vickers, Inc. — Product Code FMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1989
Date Received
September 27, 1989
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 Air-Shields Vickers, Inc.

  • K924679 — OXYCARE(TM) OXYGEN CONTROLLER/MONITOR (February 21, 1995)
  • K924297 — DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER (March 18, 1993)
  • K912908 — AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM (December 13, 1991)
  • K912909 — SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM (November 5, 1991)
  • K912910 — C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM (October 30, 1991)
  • K904691 — AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST (February 19, 1991)
  • K903378 — MODEL C286 ISOLETTE INFANT INCUBATOR (October 15, 1990)
  • K884086 — C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR (November 14, 1988)

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)