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FDA 510(k)

TEMPO AND TEMP H20

K-Number: K973748 · 1998-03-10

ApplicantSmith
Decision Date1998-03-10
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TEMPO AND TEMP H20 is the device name listed in this FDA 510(k) record. The listed applicant is Smith. It received FDA 510(k) clearance on 1998-03-10 under 510(k) number K973748. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMPO AND TEMP H20?

TEMPO AND TEMP H20 is a medical device that received FDA 510(k) clearance on 1998-03-10. The listed applicant is Smith. The 510(k) number is K973748.

When did TEMPO AND TEMP H20 receive FDA 510(k) clearance?

TEMPO AND TEMP H20 received FDA 510(k) clearance on 1998-03-10, under 510(k) number K973748.

Who is the listed applicant for TEMPO AND TEMP H20?

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

What is the FDA product code for TEMPO AND TEMP H20?

The FDA product code for TEMPO AND TEMP H20 is LGZ.

Related Clinical Trials

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Other records listing Smith 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.

K973747CONTROLLED TEMPERATURE CABINET SYSTEMK972123PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905K971092QA-ESK970555IL0292 DP ECHOPORT

Related Devices (Code: LGZ)

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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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