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FDA 510(k)

AQUA ARK, IMMERSION HYDROBATH

K-Number: K861218 · 1986-04-18

ApplicantAqua Ark, Inc.
Decision Date1986-04-18
Product CodeILJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AQUA ARK, IMMERSION HYDROBATH is the device name listed in this FDA 510(k) record. The listed applicant is Aqua Ark, Inc.. It received FDA 510(k) clearance on 1986-04-18 under 510(k) number K861218. 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 AQUA ARK, IMMERSION HYDROBATH?

AQUA ARK, IMMERSION HYDROBATH is a medical device that received FDA 510(k) clearance on 1986-04-18. The listed applicant is Aqua Ark, Inc.. The 510(k) number is K861218.

When did AQUA ARK, IMMERSION HYDROBATH receive FDA 510(k) clearance?

AQUA ARK, IMMERSION HYDROBATH received FDA 510(k) clearance on 1986-04-18, under 510(k) number K861218.

Who is the listed applicant for AQUA ARK, IMMERSION HYDROBATH?

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

What is the FDA product code for AQUA ARK, IMMERSION HYDROBATH?

The FDA product code for AQUA ARK, IMMERSION HYDROBATH is ILJ.

Related Clinical Trials

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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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