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FDA 510(k)

ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE

K-Number: K040142 · 2004-02-06

ApplicantAdac Laboratories
Decision Date2004-02-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Adac Laboratories. It received FDA 510(k) clearance on 2004-02-06 under 510(k) number K040142. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE?

ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE is a medical device that received FDA 510(k) clearance on 2004-02-06. The listed applicant is Adac Laboratories. The 510(k) number is K040142.

When did ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE receive FDA 510(k) clearance?

ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE received FDA 510(k) clearance on 2004-02-06, under 510(k) number K040142.

Who is the listed applicant for ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE?

The FDA 510(k) record lists Adac Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE?

The FDA product code for ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE is LLZ.

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Other records listing Adac Laboratories as applicant

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K062298APOLLO GAMMA CAMERA SYSTEMK061029JETSTREAM WORKSPACEK060020AUTOQUANT PLUSK051351PRECEDENCE SPECT/CT IMAGING SYSTEMK042880JETSTREAM WORKSPACEK042903AUTOSPECS

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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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