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FDA 510(k)

SENATEK

K-Number: K822993 · 1982-10-26

Decision Date1982-10-26
Product CodeHST
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SENATEK is the device name listed in this FDA 510(k) record. The listed applicant is American Health Tech., Inc.. It received FDA 510(k) clearance on 1982-10-26 under 510(k) number K822993. The device is classified under product code HST. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENATEK?

SENATEK is a medical device that received FDA 510(k) clearance on 1982-10-26. The listed applicant is American Health Tech., Inc.. The 510(k) number is K822993.

When did SENATEK receive FDA 510(k) clearance?

SENATEK received FDA 510(k) clearance on 1982-10-26, under 510(k) number K822993.

Who is the listed applicant for SENATEK?

The FDA 510(k) record lists American Health Tech., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENATEK?

The FDA product code for SENATEK is HST.

Related Clinical Trials

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.

Related Devices (Code: HST)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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