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FDA 510(k)

RESPIRATOR, BANTAM MODEL

K-Number: K781161 · 1978-12-11

ApplicantThompson Respiration Products, Inc.
Decision Date1978-12-11
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATOR, BANTAM MODEL 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 1978-12-11 under 510(k) number K781161. 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 RESPIRATOR, BANTAM MODEL?

RESPIRATOR, BANTAM MODEL is a medical device that received FDA 510(k) clearance on 1978-12-11. The listed applicant is Thompson Respiration Products, Inc.. The 510(k) number is K781161.

When did RESPIRATOR, BANTAM MODEL receive FDA 510(k) clearance?

RESPIRATOR, BANTAM MODEL received FDA 510(k) clearance on 1978-12-11, under 510(k) number K781161.

Who is the listed applicant for RESPIRATOR, BANTAM MODEL?

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 RESPIRATOR, BANTAM MODEL?

The FDA product code for RESPIRATOR, BANTAM MODEL is CBK.

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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.

K822103MODEL M3000XA VENTILATOR SPECIFICAK782174PRESSURE ALARMK781158ALARM UNIT, BATTERY OPERATEDK781160VENTILATOR, MINILUNGK781159VENTILATOR, PRESSURE

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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