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510(k) K881476

PREEMICARE MODEL D1-X1, SERIES 3000 by Preemicare Corp. — Product Code FMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1988
Date Received
April 7, 1988
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 Preemicare Corp.

  • K911450 — INFANT VENTILATOR (June 18, 1991)
  • K896375 — PREEMICARE NEBUTECH NEBULIZER SYSTEM (October 29, 1990)
  • K900735 — MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR (May 2, 1990)
  • K893622 — PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL. (January 3, 1990)
  • K893624 — PREEMICARE MODEL 2500 TRANSPORT WARMER (September 27, 1989)
  • K891674 — NEONATAL ENVIRONMENTAL MONITOR, MODEL 275 (August 31, 1989)
  • K885350 — PREEMICARE SERIES 2000 INFANT WARMER (August 7, 1989)
  • K884133 — PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP (March 8, 1989)

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  • K172154 — Isolette 8000 plus (April 19, 2018)
  • K162821 — Babyleo TN500 (June 23, 2017)
  • K152814 — Giraffe OmniBed Carestation CS1 (March 17, 2016)