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FDA 510(k)

RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO

K-Number: K001079 · 2000-05-01

ApplicantArjo, Inc.
Decision Date2000-05-01
Product CodeILJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO is the device name listed in this FDA 510(k) record. The listed applicant is Arjo, Inc.. It received FDA 510(k) clearance on 2000-05-01 under 510(k) number K001079. 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 RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO?

RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO is a medical device that received FDA 510(k) clearance on 2000-05-01. The listed applicant is Arjo, Inc.. The 510(k) number is K001079.

When did RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO receive FDA 510(k) clearance?

RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO received FDA 510(k) clearance on 2000-05-01, under 510(k) number K001079.

Who is the listed applicant for RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO?

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

What is the FDA product code for RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO?

The FDA product code for RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO is ILJ.

Related Clinical Trials

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.

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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.K012057CASCADE BATH, MODEL 6900Penner Manufacturing, Inc.K012061SUPERIOR BATH, MODEL 6300Penner 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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