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FDA 510(k)

RSI 4200

K-Number: K102831 · 2011-08-19

ApplicantReimers Systems, Inc.
Decision Date2011-08-19
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RSI 4200 is the device name listed in this FDA 510(k) record. The listed applicant is Reimers Systems, Inc.. It received FDA 510(k) clearance on 2011-08-19 under 510(k) number K102831. The device is classified under product code CBF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RSI 4200?

RSI 4200 is a medical device that received FDA 510(k) clearance on 2011-08-19. The listed applicant is Reimers Systems, Inc.. The 510(k) number is K102831.

When did RSI 4200 receive FDA 510(k) clearance?

RSI 4200 received FDA 510(k) clearance on 2011-08-19, under 510(k) number K102831.

Who is the listed applicant for RSI 4200?

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

What is the FDA product code for RSI 4200?

The FDA product code for RSI 4200 is CBF.

Other records listing Reimers Systems, 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.

K962871ODS1 - HOOD DRIVERK962869GSP1 - GAS SELECTION PANELK954387T CLASS HYPERBARIC FACILITIESK951125LIFEFORCE CLINICAL HYPERBARIC FACILITY

Related Devices (Code: CBF)

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.

K240569FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberFink Engineering Pty, Ltd.K220290Revitalair 430+Us Hyperbaric NetworkK171899Revitalair 430FOxavita SrlK163109OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc.K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control SystemOxyheal Medical Systems, Inc.K092991O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)Environmental Tectonics Corp.

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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