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FDA 510(k)

O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)

K-Number: K092991 · 2010-08-13

ApplicantEnvironmental Tectonics Corp.
Decision Date2010-08-13
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) is the device name listed in this FDA 510(k) record. The listed applicant is Environmental Tectonics Corp.. It received FDA 510(k) clearance on 2010-08-13 under 510(k) number K092991. 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 O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)?

O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) is a medical device that received FDA 510(k) clearance on 2010-08-13. The listed applicant is Environmental Tectonics Corp.. The 510(k) number is K092991.

When did O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) receive FDA 510(k) clearance?

O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) received FDA 510(k) clearance on 2010-08-13, under 510(k) number K092991.

Who is the listed applicant for O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)?

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

What is the FDA product code for O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)?

The FDA product code for O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) is CBF.

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 Environmental Tectonics Corp. 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.

K020974BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBERK993010BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER

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

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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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