FDA 510(k)

PHILIPS TOMOSCAN SR 4000

K-Number: K936272 · 1994-10-11

ApplicantPhilips Medical Systems North America, Inc.

Decision Date1994-10-11

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PHILIPS TOMOSCAN SR 4000 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 1994-10-11 under 510(k) number K936272. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILIPS TOMOSCAN SR 4000?

PHILIPS TOMOSCAN SR 4000 is a medical device that received FDA 510(k) clearance on 1994-10-11. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K936272.

When did PHILIPS TOMOSCAN SR 4000 receive FDA 510(k) clearance?

PHILIPS TOMOSCAN SR 4000 received FDA 510(k) clearance on 1994-10-11, under 510(k) number K936272.

Who is the listed applicant for PHILIPS TOMOSCAN SR 4000?

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 TOMOSCAN SR 4000?

The FDA product code for PHILIPS TOMOSCAN SR 4000 is JAK.

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Other records listing Philips Medical Systems North America, Inc. as applicant

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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.