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FDA 510(k)

SMARTMONITOR 2PS

K-Number: K061256 · 2006-08-02

ApplicantRespironics, Inc.
Decision Date2006-08-02
Product CodeNPF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SMARTMONITOR 2PS is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2006-08-02 under 510(k) number K061256. 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 2PS?

SMARTMONITOR 2PS is a medical device that received FDA 510(k) clearance on 2006-08-02. The listed applicant is Respironics, Inc.. The 510(k) number is K061256.

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

SMARTMONITOR 2PS received FDA 510(k) clearance on 2006-08-02, under 510(k) number K061256.

Who is the listed applicant for SMARTMONITOR 2PS?

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 2PS?

The FDA product code for SMARTMONITOR 2PS is NPF.

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Other records listing Respironics, Inc. as applicant

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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.

K032403SMARTMONITOR 2 PROFESSIONAL SERIES (PS)Respironics, 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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