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FDA 510(k)

ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA

K-Number: K052335 · 2005-11-23

ApplicantAccutron, Inc.
Decision Date2005-11-23
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA is the device name listed in this FDA 510(k) record. The listed applicant is Accutron, Inc.. It received FDA 510(k) clearance on 2005-11-23 under 510(k) number K052335. 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 ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA?

ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA is a medical device that received FDA 510(k) clearance on 2005-11-23. The listed applicant is Accutron, Inc.. The 510(k) number is K052335.

When did ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA receive FDA 510(k) clearance?

ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA received FDA 510(k) clearance on 2005-11-23, under 510(k) number K052335.

Who is the listed applicant for ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA?

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

What is the FDA product code for ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA?

The FDA product code for ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA is BSZ.

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Other records listing Accutron, 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.

K033503RFS VACUUM GAUGE SCAVENGING CIRCUITK992421GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076K965239PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U)K970046UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550)

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

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

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