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FDA 510(k)

ECCO GENERATOR

K-Number: K811198 · 1981-06-29

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1981-06-29
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECCO GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 1981-06-29 under 510(k) number K811198. The device is classified under product code IZO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECCO GENERATOR?

ECCO GENERATOR is a medical device that received FDA 510(k) clearance on 1981-06-29. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K811198.

When did ECCO GENERATOR receive FDA 510(k) clearance?

ECCO GENERATOR received FDA 510(k) clearance on 1981-06-29, under 510(k) number K811198.

Who is the listed applicant for ECCO GENERATOR?

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

What is the FDA product code for ECCO GENERATOR?

The FDA product code for ECCO GENERATOR is IZO.

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Other records listing Philips Medical Systems (Cleveland), Inc. as applicant

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Related Devices (Code: IZO)

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.

K954666MPH50, MPH65, AND MPH80GE Medical SystemsK953582HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATORVarian Canada, Inc.K953831N 800 HFNucletron-Oldelft Corp.K952822SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150GShimadzu Corp.K952265MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATORControl-X, Inc.K950883POLYDOROS SX 65 AND 80Siemens Medical Solutions USA, Inc.

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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