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510(k) K103317

RESUSCITATION UNIT 105 by Atom Medical Corporation — Product Code BZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2011
Date Received
November 10, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixer, Breathing Gases, Anesthesia Inhalation
Device Class
Class II
Regulation Number
868.5330
Review Panel
AN
Submission Type

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  • K102542 — RESUSCI FLOW; RESUSCI FLOW 104 (April 6, 2011)
  • K103828 — BILI-THERAPY SPOT TYPE (March 29, 2011)
  • K102227 — INFA WARMER I (January 21, 2011)
  • K102226 — DUAL INCU I (January 4, 2011)
  • K102279 — INCU I (December 29, 2010)
  • K102710 — NEO-SERVO I (December 22, 2010)

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