FDA 510(k)

ISOL-AIDE

K-Number: K915287 · 1992-10-16

Decision Date1992-10-16

Product CodeCBN

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ISOL-AIDE is the device name listed in this FDA 510(k) record. The listed applicant is Computronic Systems. It received FDA 510(k) clearance on 1992-10-16 under 510(k) number K915287. The device is classified under product code CBN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOL-AIDE?

ISOL-AIDE is a medical device that received FDA 510(k) clearance on 1992-10-16. The listed applicant is Computronic Systems. The 510(k) number is K915287.

When did ISOL-AIDE receive FDA 510(k) clearance?

ISOL-AIDE received FDA 510(k) clearance on 1992-10-16, under 510(k) number K915287.

Who is the listed applicant for ISOL-AIDE?

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

What is the FDA product code for ISOL-AIDE?

The FDA product code for ISOL-AIDE is CBN.

Related Devices (Code: CBN)

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.

K223452Nitronox Scavenger PlusParker Hannifin Corporation K193646Dynamic Gas Scavenging System 2 (DGSS - 2)Anesthetic Gas Reclamation, Inc.K160950MINISCAVSedation Systems, LLC K123176ISO-GARD CLEARAIR MASKTeleflexmedical, Inc.K110930ACTIVE WASTE GAS SCAVENGERG. Dundas Co.,Inc.K092031VAPOR-CLEAR, MODEL 100Axon Medical, 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.