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FDA 510(k)

VOLUME VENTILATOR

K-Number: K832508 · 1983-12-27

ApplicantSechrist Industries, Inc.
Decision Date1983-12-27
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VOLUME VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Sechrist Industries, Inc.. It received FDA 510(k) clearance on 1983-12-27 under 510(k) number K832508. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOLUME VENTILATOR?

VOLUME VENTILATOR is a medical device that received FDA 510(k) clearance on 1983-12-27. The listed applicant is Sechrist Industries, Inc.. The 510(k) number is K832508.

When did VOLUME VENTILATOR receive FDA 510(k) clearance?

VOLUME VENTILATOR received FDA 510(k) clearance on 1983-12-27, under 510(k) number K832508.

Who is the listed applicant for VOLUME VENTILATOR?

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

What is the FDA product code for VOLUME VENTILATOR?

The FDA product code for VOLUME VENTILATOR is CBK.

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Other records listing Sechrist Industries, 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.

K100268SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBERK052713MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBERK023745SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-GK993167MILLENNIUM INFANT VENTILATORK992503SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIESK934164MODEL 2500E/2500ER HYPERBARIC CHAMBER

View all 22 devices →

Related Devices (Code: CBK)

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.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen 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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