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FDA 510(k)

SUPERIOR BATH, MODEL 6300

K-Number: K012061 · 2001-07-19

ApplicantPenner Manufacturing, Inc.
Decision Date2001-07-19
Product CodeILJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SUPERIOR BATH, MODEL 6300 is the device name listed in this FDA 510(k) record. The listed applicant is Penner Manufacturing, Inc.. It received FDA 510(k) clearance on 2001-07-19 under 510(k) number K012061. 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 SUPERIOR BATH, MODEL 6300?

SUPERIOR BATH, MODEL 6300 is a medical device that received FDA 510(k) clearance on 2001-07-19. The listed applicant is Penner Manufacturing, Inc.. The 510(k) number is K012061.

When did SUPERIOR BATH, MODEL 6300 receive FDA 510(k) clearance?

SUPERIOR BATH, MODEL 6300 received FDA 510(k) clearance on 2001-07-19, under 510(k) number K012061.

Who is the listed applicant for SUPERIOR BATH, MODEL 6300?

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

What is the FDA product code for SUPERIOR BATH, MODEL 6300?

The FDA product code for SUPERIOR BATH, MODEL 6300 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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Other records listing Penner Manufacturing, Inc. as applicant

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.

K040772PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEMK012057CASCADE BATH, MODEL 6900

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.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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