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FDA 510(k)

HYDRO/BUBBLE BATH DEVICE 300

K-Number: K842641 · 1984-07-25

ApplicantHeddernheimer Metallwarenfabrik GmbH
Decision Date1984-07-25
Product CodeILJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HYDRO/BUBBLE BATH DEVICE 300 is the device name listed in this FDA 510(k) record. The listed applicant is Heddernheimer Metallwarenfabrik GmbH. It received FDA 510(k) clearance on 1984-07-25 under 510(k) number K842641. 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 HYDRO/BUBBLE BATH DEVICE 300?

HYDRO/BUBBLE BATH DEVICE 300 is a medical device that received FDA 510(k) clearance on 1984-07-25. The listed applicant is Heddernheimer Metallwarenfabrik GmbH. The 510(k) number is K842641.

When did HYDRO/BUBBLE BATH DEVICE 300 receive FDA 510(k) clearance?

HYDRO/BUBBLE BATH DEVICE 300 received FDA 510(k) clearance on 1984-07-25, under 510(k) number K842641.

Who is the listed applicant for HYDRO/BUBBLE BATH DEVICE 300?

The FDA 510(k) record lists Heddernheimer Metallwarenfabrik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYDRO/BUBBLE BATH DEVICE 300?

The FDA product code for HYDRO/BUBBLE BATH DEVICE 300 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 Heddernheimer Metallwarenfabrik GmbH 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.

K842642BALSAN 700K842643MASSAPED

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.K012061SUPERIOR BATH, MODEL 6300Penner 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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