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FDA 510(k)

MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER

K-Number: K052713 · 2005-10-28

ApplicantSechrist Industries, Inc.
Decision Date2005-10-28
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Sechrist Industries, Inc.. It received FDA 510(k) clearance on 2005-10-28 under 510(k) number K052713. 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 MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER?

MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER is a medical device that received FDA 510(k) clearance on 2005-10-28. The listed applicant is Sechrist Industries, Inc.. The 510(k) number is K052713.

When did MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER receive FDA 510(k) clearance?

MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER received FDA 510(k) clearance on 2005-10-28, under 510(k) number K052713.

Who is the listed applicant for MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER?

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

What is the FDA product code for MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER?

The FDA product code for MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER is CBF.

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Other records listing Sechrist Industries, 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.

K100268SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBERK023745SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-GK993167MILLENNIUM INFANT VENTILATORK992503SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIESK934164MODEL 2500E/2500ER HYPERBARIC CHAMBERK950386MODEL 3200P/3200PR HYPERBARIC CHAMBER

View all 22 devices →

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.K102831RSI 4200Reimers Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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