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FDA 510(k)

CONCHO PEDIATRIC PACK

K-Number: K820878 · 1982-05-03

ApplicantRci, Inc.
Decision Date1982-05-03
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CONCHO PEDIATRIC PACK is the device name listed in this FDA 510(k) record. The listed applicant is Rci, Inc.. It received FDA 510(k) clearance on 1982-05-03 under 510(k) number K820878. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONCHO PEDIATRIC PACK?

CONCHO PEDIATRIC PACK is a medical device that received FDA 510(k) clearance on 1982-05-03. The listed applicant is Rci, Inc.. The 510(k) number is K820878.

When did CONCHO PEDIATRIC PACK receive FDA 510(k) clearance?

CONCHO PEDIATRIC PACK received FDA 510(k) clearance on 1982-05-03, under 510(k) number K820878.

Who is the listed applicant for CONCHO PEDIATRIC PACK?

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

What is the FDA product code for CONCHO PEDIATRIC PACK?

The FDA product code for CONCHO PEDIATRIC PACK is BTT.

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 Rci, 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.

K823089RCI EARMATE

Related Devices (Code: BTT)

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.

K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare LimitedK254078HVT 2.0Vapotherm, Inc.K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallMedline Industries, LP

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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