Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CASCADE BATH, MODEL 6900

K-Number: K012057 · 2001-07-19

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

Device Summary

CASCADE BATH, MODEL 6900 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 K012057. 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 CASCADE BATH, MODEL 6900?

CASCADE BATH, MODEL 6900 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 K012057.

When did CASCADE BATH, MODEL 6900 receive FDA 510(k) clearance?

CASCADE BATH, MODEL 6900 received FDA 510(k) clearance on 2001-07-19, under 510(k) number K012057.

Who is the listed applicant for CASCADE BATH, MODEL 6900?

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 CASCADE BATH, MODEL 6900?

The FDA product code for CASCADE BATH, MODEL 6900 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SYSTEMK012061SUPERIOR BATH, MODEL 6300

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.K012061SUPERIOR BATH, MODEL 6300Penner 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.

↑