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FDA 510(k)

MODIFICATION TO: SPIRIT

K-Number: K080023 · 2008-06-16

ApplicantCaire, Inc.
Decision Date2008-06-16
Product CodeBYJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: SPIRIT is the device name listed in this FDA 510(k) record. The listed applicant is Caire, Inc.. It received FDA 510(k) clearance on 2008-06-16 under 510(k) number K080023. The device is classified under product code BYJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: SPIRIT?

MODIFICATION TO: SPIRIT is a medical device that received FDA 510(k) clearance on 2008-06-16. The listed applicant is Caire, Inc.. The 510(k) number is K080023.

When did MODIFICATION TO: SPIRIT receive FDA 510(k) clearance?

MODIFICATION TO: SPIRIT received FDA 510(k) clearance on 2008-06-16, under 510(k) number K080023.

Who is the listed applicant for MODIFICATION TO: SPIRIT?

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

What is the FDA product code for MODIFICATION TO: SPIRIT?

The FDA product code for MODIFICATION TO: SPIRIT is BYJ.

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 Caire, 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.

K250671FreeStyle Comfort (AS200 / FreeStyle Comfort)K120785OMNI 3 OXYGEN SYSTEMK121167CAIRE COMPANION 5 OXYGEN CONCENTRATORK050153SPIRIT, MODEL HASK013251SPIRIT 300K952268MODEL DELTA, OM OXYGEN CONCENTRATOR

View all 7 devices →

Related Devices (Code: BYJ)

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.

K130068DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)Essex Industries, Inc. D/B/A Essex Cryogenics of MK113767MOUNTED MEDICAL OXYGEN SYSTEMEssex Industries, Inc.K103324PRECISION LIQUID OXYGEN SYSTEMPrecision Medical, Inc.K101272MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3Essex Industries, Inc.K081779GOLOX-93Respironics, Inc.K072723RESPIRONICS GOLOXRespironics, 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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