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FDA 510(k)

MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT

K-Number: K082539 · 2008-12-02

ApplicantCardinal Health Germany 234 GmbH
Decision Date2008-12-02
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health Germany 234 GmbH. It received FDA 510(k) clearance on 2008-12-02 under 510(k) number K082539. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT?

MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT is a medical device that received FDA 510(k) clearance on 2008-12-02. The listed applicant is Cardinal Health Germany 234 GmbH. The 510(k) number is K082539.

When did MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT receive FDA 510(k) clearance?

MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT received FDA 510(k) clearance on 2008-12-02, under 510(k) number K082539.

Who is the listed applicant for MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT?

The FDA 510(k) record lists Cardinal Health Germany 234 GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT?

The FDA product code for MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT is BTY.

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Other records listing Cardinal Health Germany 234 GmbH 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: BTY)

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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Official Source

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