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FDA 510(k)

VICHY SHOWER

K-Number: K980909 · 1998-08-11

ApplicantBouvier Hydro, Inc.
Decision Date1998-08-11
Product CodeILJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

VICHY SHOWER is the device name listed in this FDA 510(k) record. The listed applicant is Bouvier Hydro, Inc.. It received FDA 510(k) clearance on 1998-08-11 under 510(k) number K980909. The device is classified under product code ILJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VICHY SHOWER?

VICHY SHOWER is a medical device that received FDA 510(k) clearance on 1998-08-11. The listed applicant is Bouvier Hydro, Inc.. The 510(k) number is K980909.

When did VICHY SHOWER receive FDA 510(k) clearance?

VICHY SHOWER received FDA 510(k) clearance on 1998-08-11, under 510(k) number K980909.

Who is the listed applicant for VICHY SHOWER?

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

What is the FDA product code for VICHY SHOWER?

The FDA product code for VICHY SHOWER is ILJ.

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Other records listing Bouvier Hydro, Inc. 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.

K980920EQUINOXE

Related Devices (Code: ILJ)

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.

K110994PARKER 500Arjohuntleigh, Inc.K082951IMMERSION HYDROBATHArjo Hospital Equipment ABK052479MBATH 1000 (60)Enneking Medical, Inc.K040772PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEMPenner Manufacturing, Inc.K012061SUPERIOR BATH, MODEL 6300Penner Manufacturing, Inc.K012057CASCADE BATH, MODEL 6900Penner Manufacturing, Inc.

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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