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510(k) K950143

ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE by Astral, Ltd. — Product Code FMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1995
Date Received
January 13, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Infant Radiant
Device Class
Class II
Regulation Number
880.5130
Review Panel
HO
Submission Type

Other clearances by Astral, Ltd.

  • K946005 — ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE (September 25, 1995)
  • K930197 — KWIK BOARD (April 20, 1993)

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