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FDA 510(k)

SIGNALDRESS

K-Number: K962590 · 1996-09-20

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1996-09-20
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

SIGNALDRESS is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. It received FDA 510(k) clearance on 1996-09-20 under 510(k) number K962590. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the SIGNALDRESS?

SIGNALDRESS is a medical device that received FDA 510(k) clearance on 1996-09-20. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K962590.

When did SIGNALDRESS receive FDA 510(k) clearance?

SIGNALDRESS received FDA 510(k) clearance on 1996-09-20, under 510(k) number K962590.

Who is the listed applicant for SIGNALDRESS?

The FDA 510(k) record lists Convatec, A Division of E.R. Squibb & Sons as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGNALDRESS?

The FDA product code for SIGNALDRESS is FRO. This falls under the Anesthesiology category.

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Other records listing Convatec, A Division of E.R. Squibb & Sons 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.

K013814ABSORBENT ANTIMICROBIAL WOUND DRESSINGK990964SIGNADRESS DUODERM DRESSINGK984388HA ABSORBENT WOUND DRESSINGK980720NONWOVEN PADK980382NON-WOVEN COMPRESSK974823NONWOVEN DRESSING

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Related Devices (Code: FRO)

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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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