FDA 510(k)

HYDRA FITNESS MODEL 311 TOTAL POWER

K-Number: K926314 · 1994-03-18

Decision Date1994-03-18

Product CodeISD

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

HYDRA FITNESS MODEL 311 TOTAL POWER is the device name listed in this FDA 510(k) record. The listed applicant is Henley Intl.. It received FDA 510(k) clearance on 1994-03-18 under 510(k) number K926314. The device is classified under product code ISD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRA FITNESS MODEL 311 TOTAL POWER?

HYDRA FITNESS MODEL 311 TOTAL POWER is a medical device that received FDA 510(k) clearance on 1994-03-18. The listed applicant is Henley Intl.. The 510(k) number is K926314.

When did HYDRA FITNESS MODEL 311 TOTAL POWER receive FDA 510(k) clearance?

HYDRA FITNESS MODEL 311 TOTAL POWER received FDA 510(k) clearance on 1994-03-18, under 510(k) number K926314.

Who is the listed applicant for HYDRA FITNESS MODEL 311 TOTAL POWER?

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

What is the FDA product code for HYDRA FITNESS MODEL 311 TOTAL POWER?

The FDA product code for HYDRA FITNESS MODEL 311 TOTAL POWER is ISD.

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Other records listing Henley Intl. as applicant

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Related Devices (Code: ISD)

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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.