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FDA 510(k)

RESPIRATOR, PROTABLE, VOLUME CONTROLLED

K-Number: K771039 · 1977-08-05

ApplicantDept. of the Navy
Decision Date1977-08-05
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATOR, PROTABLE, VOLUME CONTROLLED is the device name listed in this FDA 510(k) record. The listed applicant is Dept. of the Navy. It received FDA 510(k) clearance on 1977-08-05 under 510(k) number K771039. 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, PROTABLE, VOLUME CONTROLLED?

RESPIRATOR, PROTABLE, VOLUME CONTROLLED is a medical device that received FDA 510(k) clearance on 1977-08-05. The listed applicant is Dept. of the Navy. The 510(k) number is K771039.

When did RESPIRATOR, PROTABLE, VOLUME CONTROLLED receive FDA 510(k) clearance?

RESPIRATOR, PROTABLE, VOLUME CONTROLLED received FDA 510(k) clearance on 1977-08-05, under 510(k) number K771039.

Who is the listed applicant for RESPIRATOR, PROTABLE, VOLUME CONTROLLED?

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

What is the FDA product code for RESPIRATOR, PROTABLE, VOLUME CONTROLLED?

The FDA product code for RESPIRATOR, PROTABLE, VOLUME CONTROLLED is CBK.

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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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