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510(k) K101439

CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P by Codonics, Inc. — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2011
Date Received
May 24, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas-Machine, Anesthesia
Device Class
Class II
Regulation Number
868.5160
Review Panel
AN
Submission Type

Other clearances by Codonics, Inc.

  • K060440 — CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG (March 16, 2006)
  • K042232 — NP-2600 SERIES HARDCOPY PRINTERS (October 5, 2004)
  • K030690 — CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS (April 30, 2003)
  • K021054 — CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL M (May 9, 2002)
  • K003481 — CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660 (January 19, 2001)
  • K962364 — CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD) (November 8, 1996)

Other clearances for product code BSZ

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  • K213867 — Carestation 750/750c (March 28, 2023)
  • K201957 — A8, A9 Anesthesia System (March 26, 2021)
  • K191027 — Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System (March 18, 2020)
  • K171292 — A7 Anesthesia System (January 12, 2018)
  • K171311 — A5 Anesthesia System (January 12, 2018)
  • K172045 — Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aesp (November 3, 2017)
  • K170872 — Aisys CS2 (August 15, 2017)
  • K160665 — FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia Sy (March 29, 2017)