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FDA 510(k)

SRS-200 RADIOSURGERY SYSTEM

K-Number: K891292 · 1989-09-18

ApplicantPhilips Medical Systems North America, Inc.
Decision Date1989-09-18
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SRS-200 RADIOSURGERY SYSTEM 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 1989-09-18 under 510(k) number K891292. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SRS-200 RADIOSURGERY SYSTEM?

SRS-200 RADIOSURGERY SYSTEM is a medical device that received FDA 510(k) clearance on 1989-09-18. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K891292.

When did SRS-200 RADIOSURGERY SYSTEM receive FDA 510(k) clearance?

SRS-200 RADIOSURGERY SYSTEM received FDA 510(k) clearance on 1989-09-18, under 510(k) number K891292.

Who is the listed applicant for SRS-200 RADIOSURGERY SYSTEM?

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 SRS-200 RADIOSURGERY SYSTEM?

The FDA product code for SRS-200 RADIOSURGERY SYSTEM is IYE.

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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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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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