FDA 510(k)

4000+

K-Number: K950783 · 1995-10-27

Decision Date1995-10-27

Product CodeIPF

Advisory CommitteePM

DecisionSubstantially Equivalent for Some Indications

Device Summary

4000+ is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Therapy Products, Inc.. It received FDA 510(k) clearance on 1995-10-27 under 510(k) number K950783. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the 4000+?

4000+ is a medical device that received FDA 510(k) clearance on 1995-10-27. The listed applicant is U.S. Therapy Products, Inc.. The 510(k) number is K950783.

When did 4000+ receive FDA 510(k) clearance?

4000+ received FDA 510(k) clearance on 1995-10-27, under 510(k) number K950783.

Who is the listed applicant for 4000+?

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

What is the FDA product code for 4000+?

The FDA product code for 4000+ is IPF.

Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali Nezakati K260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.