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FDA 510(k)

IMMERSION HYDROBATH

K-Number: K082951 · 2009-04-08

ApplicantArjo Hospital Equipment AB
Decision Date2009-04-08
Product CodeILJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

IMMERSION HYDROBATH is the device name listed in this FDA 510(k) record. The listed applicant is Arjo Hospital Equipment AB. It received FDA 510(k) clearance on 2009-04-08 under 510(k) number K082951. 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 IMMERSION HYDROBATH?

IMMERSION HYDROBATH is a medical device that received FDA 510(k) clearance on 2009-04-08. The listed applicant is Arjo Hospital Equipment AB. The 510(k) number is K082951.

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

IMMERSION HYDROBATH received FDA 510(k) clearance on 2009-04-08, under 510(k) number K082951.

Who is the listed applicant for IMMERSION HYDROBATH?

The FDA 510(k) record lists Arjo Hospital Equipment AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMERSION HYDROBATH?

The FDA product code for IMMERSION HYDROBATH 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.K052479MBATH 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.K001079RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMOArjo, Inc.

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.

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