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FDA 510(k)

OASIS CLUB HYDROMASSAGE

K-Number: K841954 · 1984-05-23

ApplicantPrexcor America, Inc.
Decision Date1984-05-23
Product CodeILJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OASIS CLUB HYDROMASSAGE is the device name listed in this FDA 510(k) record. The listed applicant is Prexcor America, Inc.. It received FDA 510(k) clearance on 1984-05-23 under 510(k) number K841954. 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 OASIS CLUB HYDROMASSAGE?

OASIS CLUB HYDROMASSAGE is a medical device that received FDA 510(k) clearance on 1984-05-23. The listed applicant is Prexcor America, Inc.. The 510(k) number is K841954.

When did OASIS CLUB HYDROMASSAGE receive FDA 510(k) clearance?

OASIS CLUB HYDROMASSAGE received FDA 510(k) clearance on 1984-05-23, under 510(k) number K841954.

Who is the listed applicant for OASIS CLUB HYDROMASSAGE?

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

What is the FDA product code for OASIS CLUB HYDROMASSAGE?

The FDA product code for OASIS CLUB HYDROMASSAGE is ILJ.

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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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