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FDA 510(k)

PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION

K-Number: K945460 · 1995-03-14

ApplicantPhilips Medical Systems North America, Inc.
Decision Date1995-03-14
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems North America, Inc.. It received FDA 510(k) clearance on 1995-03-14 under 510(k) number K945460. 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 CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION?

PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION is a medical device that received FDA 510(k) clearance on 1995-03-14. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K945460.

When did PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION receive FDA 510(k) clearance?

PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION received FDA 510(k) clearance on 1995-03-14, under 510(k) number K945460.

Who is the listed applicant for PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION?

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

What is the FDA product code for PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION?

The FDA product code for PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION is JAA.

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Other records listing Philips Medical Systems North America, 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.

K102005ALLURA XPER OR TABLE SERIESK062233HEARTSTART MRX MONITOR/DEFIBRILLATORK062283THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORSK061052THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90K050151MULTIDIAGNOST ELEVAK042867PHILIPS ORTHOPAEDIC APPLICATIONS

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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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