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FDA 510(k)

SMARTMONITOR 2, MODEL 4000

K-Number: K011597 · 2002-01-11

ApplicantRespironics Georgia, Inc.
Decision Date2002-01-11
Product CodeFLS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SMARTMONITOR 2, MODEL 4000 is the device name listed in this FDA 510(k) record. The listed applicant is Respironics Georgia, Inc.. It received FDA 510(k) clearance on 2002-01-11 under 510(k) number K011597. The device is classified under product code FLS. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTMONITOR 2, MODEL 4000?

SMARTMONITOR 2, MODEL 4000 is a medical device that received FDA 510(k) clearance on 2002-01-11. The listed applicant is Respironics Georgia, Inc.. The 510(k) number is K011597.

When did SMARTMONITOR 2, MODEL 4000 receive FDA 510(k) clearance?

SMARTMONITOR 2, MODEL 4000 received FDA 510(k) clearance on 2002-01-11, under 510(k) number K011597.

Who is the listed applicant for SMARTMONITOR 2, MODEL 4000?

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

What is the FDA product code for SMARTMONITOR 2, MODEL 4000?

The FDA product code for SMARTMONITOR 2, MODEL 4000 is FLS.

Related Clinical Trials

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Other records listing Respironics Georgia, 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.

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Related Devices (Code: FLS)

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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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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