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FDA 510(k)

FERNO HEALTHCARE RECLINE-A-BATH 2

K-Number: K980033 · 1998-04-21

ApplicantFerno-Washington, Inc.
Decision Date1998-04-21
Product CodeILJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FERNO HEALTHCARE RECLINE-A-BATH 2 is the device name listed in this FDA 510(k) record. The listed applicant is Ferno-Washington, Inc.. It received FDA 510(k) clearance on 1998-04-21 under 510(k) number K980033. 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 FERNO HEALTHCARE RECLINE-A-BATH 2?

FERNO HEALTHCARE RECLINE-A-BATH 2 is a medical device that received FDA 510(k) clearance on 1998-04-21. The listed applicant is Ferno-Washington, Inc.. The 510(k) number is K980033.

When did FERNO HEALTHCARE RECLINE-A-BATH 2 receive FDA 510(k) clearance?

FERNO HEALTHCARE RECLINE-A-BATH 2 received FDA 510(k) clearance on 1998-04-21, under 510(k) number K980033.

Who is the listed applicant for FERNO HEALTHCARE RECLINE-A-BATH 2?

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

What is the FDA product code for FERNO HEALTHCARE RECLINE-A-BATH 2?

The FDA product code for FERNO HEALTHCARE RECLINE-A-BATH 2 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 Ferno-Washington, 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.

K932417FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-ITK864765MODEL 668, TRACTION SPLINT, ADULTK864269MODEL 35-B ALL LEVEL COTK862441EZ LOAD MODEL 30, ALL LEVEL COT

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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