FDA 510(k)

PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A

K-Number: K042306 · 2004-10-15

ApplicantPhilips Medizin Systeme Boeblingen GmbH

Decision Date2004-10-15

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. It received FDA 510(k) clearance on 2004-10-15 under 510(k) number K042306. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A?

PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A is a medical device that received FDA 510(k) clearance on 2004-10-15. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K042306.

When did PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A receive FDA 510(k) clearance?

PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A received FDA 510(k) clearance on 2004-10-15, under 510(k) number K042306.

Who is the listed applicant for PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A?

The FDA 510(k) record lists Philips Medizin Systeme Boeblingen GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A?

The FDA product code for PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A is DQA.

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Related Devices (Code: DQA)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.