FDA 510(k)

THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT

K-Number: K041674 · 2004-07-19

Decision Date2004-07-19

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2004-07-19 under 510(k) number K041674. 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 THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT?

THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT is a medical device that received FDA 510(k) clearance on 2004-07-19. The listed applicant is Philips Medical Systems. The 510(k) number is K041674.

When did THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT receive FDA 510(k) clearance?

THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT received FDA 510(k) clearance on 2004-07-19, under 510(k) number K041674.

Who is the listed applicant for THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT?

The FDA 510(k) record lists Philips Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT?

The FDA product code for THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT is 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.