FDA 510(k) Search

K Number

Device Name

Codonics 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)

Manufacturer

Codonics.Incorporated

Date Cleared

2025-07-11

Product Code

BSZ

Regulation Number

868.5160

Intended Use

PDF not available yet

Device Description

PDF not available yet

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

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Street 2

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Class Advise Committee

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Third Party Reviewed

Expedited Review

AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Summary

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View FDA Record ↗