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FDA 510(k)

NAUTILUS MONOPLACE HYPERBARIC UNIT

K-Number: K832127 · 1983-08-12

ApplicantNautilus Environmedical Systems, Inc.
Decision Date1983-08-12
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NAUTILUS MONOPLACE HYPERBARIC UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Nautilus Environmedical Systems, Inc.. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K832127. 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 NAUTILUS MONOPLACE HYPERBARIC UNIT?

NAUTILUS MONOPLACE HYPERBARIC UNIT is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Nautilus Environmedical Systems, Inc.. The 510(k) number is K832127.

When did NAUTILUS MONOPLACE HYPERBARIC UNIT receive FDA 510(k) clearance?

NAUTILUS MONOPLACE HYPERBARIC UNIT received FDA 510(k) clearance on 1983-08-12, under 510(k) number K832127.

Who is the listed applicant for NAUTILUS MONOPLACE HYPERBARIC UNIT?

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

What is the FDA product code for NAUTILUS MONOPLACE HYPERBARIC UNIT?

The FDA product code for NAUTILUS MONOPLACE HYPERBARIC UNIT 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 Nautilus Environmedical 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.

K850563SECHRIST VENTILATOR/NAUTILUS CHAMBER COMBINATION

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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