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FDA 510(k)

ACCESSORY FOR ADULT VOL. VENTILATOR

K-Number: K842580 · 1984-08-24

ApplicantInfrasonics Corp.
Decision Date1984-08-24
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ACCESSORY FOR ADULT VOL. VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Infrasonics Corp.. It received FDA 510(k) clearance on 1984-08-24 under 510(k) number K842580. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESSORY FOR ADULT VOL. VENTILATOR?

ACCESSORY FOR ADULT VOL. VENTILATOR is a medical device that received FDA 510(k) clearance on 1984-08-24. The listed applicant is Infrasonics Corp.. The 510(k) number is K842580.

When did ACCESSORY FOR ADULT VOL. VENTILATOR receive FDA 510(k) clearance?

ACCESSORY FOR ADULT VOL. VENTILATOR received FDA 510(k) clearance on 1984-08-24, under 510(k) number K842580.

Who is the listed applicant for ACCESSORY FOR ADULT VOL. VENTILATOR?

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

What is the FDA product code for ACCESSORY FOR ADULT VOL. VENTILATOR?

The FDA product code for ACCESSORY FOR ADULT VOL. VENTILATOR is CAH.

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Other records listing Infrasonics Corp. 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.

K943106ADULT VENTILATORK952878OXY/STAR LOW FLOW BLENDERK934753STAR BREATHING CIRCUITSK922654VENTILATOR ADULT STAR MODIFICATIONK923704INFANT STAR SERIES 500K922477MODEL 105 VENTILATOR, MODIFICATION

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Related Devices (Code: CAH)

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.

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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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