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510(k) K854065

INFANT LIFE SUPPORT MODULE-20 by Intl. Biomedics, Inc. — Product Code FPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1986
Date Received
October 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Incubator, Neonatal Transport
Device Class
Class II
Regulation Number
880.5410
Review Panel
HO
Submission Type

Other clearances by Intl. Biomedics, Inc.

  • K882551 — AMBULATORY PH DATA RECORDER SYSTEM, APH-2000 (October 12, 1988)

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  • K103527 — AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WIT (April 15, 2011)
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  • K081399 — AVIATOR TRANSPORT INCUBATOR (June 6, 2008)
  • K061071 — V-808 ATOM TRANSCAPSULE (August 29, 2006)