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FDA 510(k)

PARKER 500

K-Number: K110994 · 2011-07-06

ApplicantArjohuntleigh, Inc.
Decision Date2011-07-06
Product CodeILJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PARKER 500 is the device name listed in this FDA 510(k) record. The listed applicant is Arjohuntleigh, Inc.. It received FDA 510(k) clearance on 2011-07-06 under 510(k) number K110994. 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 PARKER 500?

PARKER 500 is a medical device that received FDA 510(k) clearance on 2011-07-06. The listed applicant is Arjohuntleigh, Inc.. The 510(k) number is K110994.

When did PARKER 500 receive FDA 510(k) clearance?

PARKER 500 received FDA 510(k) clearance on 2011-07-06, under 510(k) number K110994.

Who is the listed applicant for PARKER 500?

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

What is the FDA product code for PARKER 500?

The FDA product code for PARKER 500 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.

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.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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