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FDA 510(k)

FOCUS PILOT CONTOURING WORKSTATION

K-Number: K981535 · 1999-04-02

ApplicantComputerized Medical Systems, Inc.
Decision Date1999-04-02
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FOCUS PILOT CONTOURING WORKSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Computerized Medical Systems, Inc.. It received FDA 510(k) clearance on 1999-04-02 under 510(k) number K981535. 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 FOCUS PILOT CONTOURING WORKSTATION?

FOCUS PILOT CONTOURING WORKSTATION is a medical device that received FDA 510(k) clearance on 1999-04-02. The listed applicant is Computerized Medical Systems, Inc.. The 510(k) number is K981535.

When did FOCUS PILOT CONTOURING WORKSTATION receive FDA 510(k) clearance?

FOCUS PILOT CONTOURING WORKSTATION received FDA 510(k) clearance on 1999-04-02, under 510(k) number K981535.

Who is the listed applicant for FOCUS PILOT CONTOURING WORKSTATION?

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

What is the FDA product code for FOCUS PILOT CONTOURING WORKSTATION?

The FDA product code for FOCUS PILOT CONTOURING WORKSTATION is IYE.

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Other records listing Computerized Medical Systems, 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.

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