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FDA 510(k)

CAMBRIDGE MODEL XT1000

K-Number: K854283 · 1985-11-13

ApplicantCambridge Medical Instruments, Inc.
Decision Date1985-11-13
Product CodeIOL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CAMBRIDGE MODEL XT1000 is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Medical Instruments, Inc.. It received FDA 510(k) clearance on 1985-11-13 under 510(k) number K854283. The device is classified under product code IOL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAMBRIDGE MODEL XT1000?

CAMBRIDGE MODEL XT1000 is a medical device that received FDA 510(k) clearance on 1985-11-13. The listed applicant is Cambridge Medical Instruments, Inc.. The 510(k) number is K854283.

When did CAMBRIDGE MODEL XT1000 receive FDA 510(k) clearance?

CAMBRIDGE MODEL XT1000 received FDA 510(k) clearance on 1985-11-13, under 510(k) number K854283.

Who is the listed applicant for CAMBRIDGE MODEL XT1000?

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

What is the FDA product code for CAMBRIDGE MODEL XT1000?

The FDA product code for CAMBRIDGE MODEL XT1000 is IOL.

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Other records listing Cambridge Medical Instruments, 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.

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Related Devices (Code: IOL)

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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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