Home / 510(k) Clearances / K913291

510(k) K913291

MODEL C386 ISOLETTE(R) INFANT INCUBATOR by Air-Shields, Inc. — Product Code FMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1991
Date Received
July 24, 1991
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, Inc.

  • K974248 — WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM (October 7, 1998)
  • K972309 — JM-102 JAUNDICE METER (September 22, 1998)
  • K971256 — DUO-LITE PHOTOTHERAPY SYSTEM (September 24, 1997)
  • K960980 — ISOLETTE INFANT INCUBATOR (July 30, 1996)
  • K924709 — SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE (January 17, 1996)
  • K940951 — RW RESUCITAIRE INFANT RADIANT WARMER (May 3, 1995)
  • K940975 — C450/C400 INFANT INCUBATORS (June 23, 1994)
  • K941106 — MODEL TI500 ISOLETTE INFANT INCUBATOR (June 10, 1994)
  • K924170 — ISOLETTE INCUBATOR HUMIDITY METER (February 5, 1993)
  • K922150 — EXAMINATION LAMP (July 21, 1992)

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)