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FDA 510(k)

YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES

K-Number: K921561 · 1992-11-23

ApplicantYsis, Inc.
Decision Date1992-11-23
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES is the device name listed in this FDA 510(k) record. The listed applicant is Ysis, Inc.. It received FDA 510(k) clearance on 1992-11-23 under 510(k) number K921561. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES?

YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES is a medical device that received FDA 510(k) clearance on 1992-11-23. The listed applicant is Ysis, Inc.. The 510(k) number is K921561.

When did YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES receive FDA 510(k) clearance?

YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES received FDA 510(k) clearance on 1992-11-23, under 510(k) number K921561.

Who is the listed applicant for YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES?

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

What is the FDA product code for YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES?

The FDA product code for YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES is EZL.

Related Clinical Trials

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Other records listing Ysis, 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.

K913806YSI MODEL 2300 STAT PLUS

Related Devices (Code: EZL)

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.

K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies,K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd.K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLCK232469Rüsch Latex Gold Foley CatheterTeleflexmedical, Inc.

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.

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