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510(k) K102710

NEO-SERVO I by Atom Medical Corporation — Product Code FMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2010
Date Received
September 20, 2010
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 Atom Medical Corporation

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  • K103317 — RESUSCITATION UNIT 105 (April 20, 2011)
  • 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)

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