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)

BURN BATH

K-Number: K841397 · 1984-05-18

ApplicantSetma, Inc.
Decision Date1984-05-18
Product CodeILJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BURN BATH is the device name listed in this FDA 510(k) record. The listed applicant is Setma, Inc.. It received FDA 510(k) clearance on 1984-05-18 under 510(k) number K841397. 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 BURN BATH?

BURN BATH is a medical device that received FDA 510(k) clearance on 1984-05-18. The listed applicant is Setma, Inc.. The 510(k) number is K841397.

When did BURN BATH receive FDA 510(k) clearance?

BURN BATH received FDA 510(k) clearance on 1984-05-18, under 510(k) number K841397.

Who is the listed applicant for BURN BATH?

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 BURN BATH?

The FDA product code for BURN BATH is ILJ.

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.

K854861SETMA HYGIA BATH MODEL ST 7200K854263SETMA FHT, MODEL ST 8130K853163SETMA VHTK841395SHOWER TROLLEYK841396TRANSFER TROLLEYK841398VARIABLE HEIGHT TRANSFER CHAIR

View all 7 devices →

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.

↑