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FDA 510(k)

IPPB ASSEMBLY W/NEBULIZER

K-Number: K781232 · 1978-09-27

ApplicantRtec
Decision Date1978-09-27
Product CodeNHJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

IPPB ASSEMBLY W/NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Rtec. It received FDA 510(k) clearance on 1978-09-27 under 510(k) number K781232. The device is classified under product code NHJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IPPB ASSEMBLY W/NEBULIZER?

IPPB ASSEMBLY W/NEBULIZER is a medical device that received FDA 510(k) clearance on 1978-09-27. The listed applicant is Rtec. The 510(k) number is K781232.

When did IPPB ASSEMBLY W/NEBULIZER receive FDA 510(k) clearance?

IPPB ASSEMBLY W/NEBULIZER received FDA 510(k) clearance on 1978-09-27, under 510(k) number K781232.

Who is the listed applicant for IPPB ASSEMBLY W/NEBULIZER?

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

What is the FDA product code for IPPB ASSEMBLY W/NEBULIZER?

The FDA product code for IPPB ASSEMBLY W/NEBULIZER is NHJ.

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 Rtec 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.

K781231OXYGEN SUPPLY TUBE, DISP., PLASTIC

Related Devices (Code: NHJ)

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.

K260604BiWaze Clear SystemAbmrc, LLCK253001KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)Hunan Ruijiong Biotech Co., Ltd.K242438ClearoBreas Medical ABK231728BiWaze Clear SystemAbmrc, LLCK213564BiWaze Clear SystemAbmrc, LLCK200988Maximus SystemHill-Rom Services Pte, 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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