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FDA 510(k)

SETMA HYGIA BATH MODEL ST 7200

K-Number: K854861 · 1986-01-03

ApplicantSetma, Inc.
Decision Date1986-01-03
Product CodeILJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SETMA HYGIA BATH MODEL ST 7200 is the device name listed in this FDA 510(k) record. The listed applicant is Setma, Inc.. It received FDA 510(k) clearance on 1986-01-03 under 510(k) number K854861. 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 SETMA HYGIA BATH MODEL ST 7200?

SETMA HYGIA BATH MODEL ST 7200 is a medical device that received FDA 510(k) clearance on 1986-01-03. The listed applicant is Setma, Inc.. The 510(k) number is K854861.

When did SETMA HYGIA BATH MODEL ST 7200 receive FDA 510(k) clearance?

SETMA HYGIA BATH MODEL ST 7200 received FDA 510(k) clearance on 1986-01-03, under 510(k) number K854861.

Who is the listed applicant for SETMA HYGIA BATH MODEL ST 7200?

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

What is the FDA product code for SETMA HYGIA BATH MODEL ST 7200?

The FDA product code for SETMA HYGIA BATH MODEL ST 7200 is ILJ.

Related Clinical Trials

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Other records listing Setma, 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.

K854263SETMA FHT, MODEL ST 8130K853163SETMA VHTK841397BURN BATHK841395SHOWER TROLLEYK841396TRANSFER TROLLEYK841398VARIABLE HEIGHT TRANSFER CHAIR

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