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510(k) K896375

PREEMICARE NEBUTECH NEBULIZER SYSTEM by Preemicare Corp. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1990
Date Received
November 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Other clearances by Preemicare Corp.

  • K911450 — INFANT VENTILATOR (June 18, 1991)
  • 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)
  • K881476 — PREEMICARE MODEL D1-X1, SERIES 3000 (December 8, 1988)

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