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FDA 510(k)

MODEL M3000XA VENTILATOR SPECIFICA

K-Number: K822103 · 1982-07-26

ApplicantThompson Respiration Products, Inc.
Decision Date1982-07-26
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL M3000XA VENTILATOR SPECIFICA is the device name listed in this FDA 510(k) record. The listed applicant is Thompson Respiration Products, Inc.. It received FDA 510(k) clearance on 1982-07-26 under 510(k) number K822103. 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 MODEL M3000XA VENTILATOR SPECIFICA?

MODEL M3000XA VENTILATOR SPECIFICA is a medical device that received FDA 510(k) clearance on 1982-07-26. The listed applicant is Thompson Respiration Products, Inc.. The 510(k) number is K822103.

When did MODEL M3000XA VENTILATOR SPECIFICA receive FDA 510(k) clearance?

MODEL M3000XA VENTILATOR SPECIFICA received FDA 510(k) clearance on 1982-07-26, under 510(k) number K822103.

Who is the listed applicant for MODEL M3000XA VENTILATOR SPECIFICA?

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

What is the FDA product code for MODEL M3000XA VENTILATOR SPECIFICA?

The FDA product code for MODEL M3000XA VENTILATOR SPECIFICA is CBK.

Related Clinical Trials

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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Other records listing Thompson Respiration Products, 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.

K782174PRESSURE ALARMK781158ALARM UNIT, BATTERY OPERATEDK781160VENTILATOR, MINILUNGK781159VENTILATOR, PRESSUREK781161RESPIRATOR, BANTAM MODEL

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

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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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