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FDA 510(k)

SPIRIT 300

K-Number: K013251 · 2001-12-18

ApplicantCaire, Inc.
Decision Date2001-12-18
Product CodeBYJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIRIT 300 is the device name listed in this FDA 510(k) record. The listed applicant is Caire, Inc.. It received FDA 510(k) clearance on 2001-12-18 under 510(k) number K013251. 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 SPIRIT 300?

SPIRIT 300 is a medical device that received FDA 510(k) clearance on 2001-12-18. The listed applicant is Caire, Inc.. The 510(k) number is K013251.

When did SPIRIT 300 receive FDA 510(k) clearance?

SPIRIT 300 received FDA 510(k) clearance on 2001-12-18, under 510(k) number K013251.

Who is the listed applicant for SPIRIT 300?

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 SPIRIT 300?

The FDA product code for SPIRIT 300 is BYJ.

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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 CONCENTRATORK080023MODIFICATION TO: SPIRITK050153SPIRIT, MODEL HASK952268MODEL 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.K080023MODIFICATION TO: SPIRITCaire, 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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