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FDA 510(k)

GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076

K-Number: K992421 · 1999-10-27

ApplicantAccutron, Inc.
Decision Date1999-10-27
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 is the device name listed in this FDA 510(k) record. The listed applicant is Accutron, Inc.. It received FDA 510(k) clearance on 1999-10-27 under 510(k) number K992421. 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 GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076?

GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 is a medical device that received FDA 510(k) clearance on 1999-10-27. The listed applicant is Accutron, Inc.. The 510(k) number is K992421.

When did GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 receive FDA 510(k) clearance?

GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 received FDA 510(k) clearance on 1999-10-27, under 510(k) number K992421.

Who is the listed applicant for GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076?

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 GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076?

The FDA product code for GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 is BSZ.

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Other records listing Accutron, Inc. as applicant

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K052335ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRAK033503RFS VACUUM GAUGE SCAVENGING CIRCUITK965239PIP 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)

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Official Source

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