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FDA 510(k)

PHILIPS INTEGRIS I 2000 SYSTEM

K-Number: K904012 · 1990-11-29

ApplicantPhilips Medical Systems, Inc.
Decision Date1990-11-29
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHILIPS INTEGRIS I 2000 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems, Inc.. It received FDA 510(k) clearance on 1990-11-29 under 510(k) number K904012. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILIPS INTEGRIS I 2000 SYSTEM?

PHILIPS INTEGRIS I 2000 SYSTEM is a medical device that received FDA 510(k) clearance on 1990-11-29. The listed applicant is Philips Medical Systems, Inc.. The 510(k) number is K904012.

When did PHILIPS INTEGRIS I 2000 SYSTEM receive FDA 510(k) clearance?

PHILIPS INTEGRIS I 2000 SYSTEM received FDA 510(k) clearance on 1990-11-29, under 510(k) number K904012.

Who is the listed applicant for PHILIPS INTEGRIS I 2000 SYSTEM?

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

What is the FDA product code for PHILIPS INTEGRIS I 2000 SYSTEM?

The FDA product code for PHILIPS INTEGRIS I 2000 SYSTEM is JAA.

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Other records listing Philips Medical Systems, 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.

K093355PCR ELEVA 1.2K090808PINNACLE3 SMARTARCK071391PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521K063783PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132AK041741M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIENK040955M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN

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Related Devices (Code: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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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