FDA 510(k)

SLS SIMULATOR (MODELS SLS-9 AND SLS-14)

K-Number: K891293 · 1989-04-20

ApplicantPhilips Medical Systems North America, Inc.

Decision Date1989-04-20

Product CodeKPQ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SLS SIMULATOR (MODELS SLS-9 AND SLS-14) 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 1989-04-20 under 510(k) number K891293. The device is classified under product code KPQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLS SIMULATOR (MODELS SLS-9 AND SLS-14)?

SLS SIMULATOR (MODELS SLS-9 AND SLS-14) is a medical device that received FDA 510(k) clearance on 1989-04-20. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K891293.

When did SLS SIMULATOR (MODELS SLS-9 AND SLS-14) receive FDA 510(k) clearance?

SLS SIMULATOR (MODELS SLS-9 AND SLS-14) received FDA 510(k) clearance on 1989-04-20, under 510(k) number K891293.

Who is the listed applicant for SLS SIMULATOR (MODELS SLS-9 AND SLS-14)?

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 SLS SIMULATOR (MODELS SLS-9 AND SLS-14)?

The FDA product code for SLS SIMULATOR (MODELS SLS-9 AND SLS-14) is KPQ.

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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.