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FDA 510(k)

MBATH 1000 (60)

K-Number: K052479 · 2006-01-26

ApplicantEnneking Medical, Inc.
Decision Date2006-01-26
Product CodeILJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MBATH 1000 (60) is the device name listed in this FDA 510(k) record. The listed applicant is Enneking Medical, Inc.. It received FDA 510(k) clearance on 2006-01-26 under 510(k) number K052479. 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 MBATH 1000 (60)?

MBATH 1000 (60) is a medical device that received FDA 510(k) clearance on 2006-01-26. The listed applicant is Enneking Medical, Inc.. The 510(k) number is K052479.

When did MBATH 1000 (60) receive FDA 510(k) clearance?

MBATH 1000 (60) received FDA 510(k) clearance on 2006-01-26, under 510(k) number K052479.

Who is the listed applicant for MBATH 1000 (60)?

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

What is the FDA product code for MBATH 1000 (60)?

The FDA product code for MBATH 1000 (60) 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 ABK040772PACIFIC 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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