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FDA 510(k)

CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P

K-Number: K101439 · 2011-02-07

ApplicantCodonics, Inc.
Decision Date2011-02-07
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P is the device name listed in this FDA 510(k) record. The listed applicant is Codonics, Inc.. It received FDA 510(k) clearance on 2011-02-07 under 510(k) number K101439. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P?

CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P is a medical device that received FDA 510(k) clearance on 2011-02-07. The listed applicant is Codonics, Inc.. The 510(k) number is K101439.

When did CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P receive FDA 510(k) clearance?

CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P received FDA 510(k) clearance on 2011-02-07, under 510(k) number K101439.

Who is the listed applicant for CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P?

The FDA 510(k) record lists Codonics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P?

The FDA product code for CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P is BSZ.

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Other records listing Codonics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K060440CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGERK042232NP-2600 SERIES HARDCOPY PRINTERSK030690CODONICS EP-1000 MEDICAL COLOR DRY IMAGERSK021054CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGERK003481CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660K962364CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD)

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Related Devices (Code: BSZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K252746Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)Drägerwerk AG Co. KgaaK251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)Codonics.IncorporatedK230931AtlanDrägerwerk AG Co. KgaaK213867Carestation 750/750cDatex-Ohmeda, Inc.K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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