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FDA 510(k)

SMARTMONITOR 2 PROFESSIONAL SERIES (PS)

K-Number: K032403 · 2003-10-27

ApplicantRespironics, Inc.
Decision Date2003-10-27
Product CodeNPF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SMARTMONITOR 2 PROFESSIONAL SERIES (PS) is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2003-10-27 under 510(k) number K032403. The device is classified under product code NPF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTMONITOR 2 PROFESSIONAL SERIES (PS)?

SMARTMONITOR 2 PROFESSIONAL SERIES (PS) is a medical device that received FDA 510(k) clearance on 2003-10-27. The listed applicant is Respironics, Inc.. The 510(k) number is K032403.

When did SMARTMONITOR 2 PROFESSIONAL SERIES (PS) receive FDA 510(k) clearance?

SMARTMONITOR 2 PROFESSIONAL SERIES (PS) received FDA 510(k) clearance on 2003-10-27, under 510(k) number K032403.

Who is the listed applicant for SMARTMONITOR 2 PROFESSIONAL SERIES (PS)?

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

What is the FDA product code for SMARTMONITOR 2 PROFESSIONAL SERIES (PS)?

The FDA product code for SMARTMONITOR 2 PROFESSIONAL SERIES (PS) is NPF.

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Related Devices (Code: NPF)

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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