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FDA 510(k)

HYPERBARIC PENETRATION EXTENSION SET

K-Number: K861315 · 1986-05-21

ApplicantCutter Laboratories, Inc.
Decision Date1986-05-21
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HYPERBARIC PENETRATION EXTENSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Cutter Laboratories, Inc.. It received FDA 510(k) clearance on 1986-05-21 under 510(k) number K861315. 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 HYPERBARIC PENETRATION EXTENSION SET?

HYPERBARIC PENETRATION EXTENSION SET is a medical device that received FDA 510(k) clearance on 1986-05-21. The listed applicant is Cutter Laboratories, Inc.. The 510(k) number is K861315.

When did HYPERBARIC PENETRATION EXTENSION SET receive FDA 510(k) clearance?

HYPERBARIC PENETRATION EXTENSION SET received FDA 510(k) clearance on 1986-05-21, under 510(k) number K861315.

Who is the listed applicant for HYPERBARIC PENETRATION EXTENSION SET?

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

What is the FDA product code for HYPERBARIC PENETRATION EXTENSION SET?

The FDA product code for HYPERBARIC PENETRATION EXTENSION SET is CBF.

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Other records listing Cutter Laboratories, Inc. as applicant

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K854106BAYSILEXK842324PERFOURMK834106INTRAVENOUS INFUSION CONTROLLERK832237ORTHOPEDIC CASTING TAPE MAXCASTK823214DOSIMETRIC RELEASE PROGRAM - ADMIN. SETK821326CUTTER BOND POLYCARBOXYLATE CEMENT

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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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