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FDA 510(k)

MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE

K-Number: K944673 · 1996-04-10

ApplicantRegulatory & Marketing Services, Inc.
Decision Date1996-04-10
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Regulatory & Marketing Services, Inc.. It received FDA 510(k) clearance on 1996-04-10 under 510(k) number K944673. 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 MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE?

MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE is a medical device that received FDA 510(k) clearance on 1996-04-10. The listed applicant is Regulatory & Marketing Services, Inc.. The 510(k) number is K944673.

When did MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE receive FDA 510(k) clearance?

MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE received FDA 510(k) clearance on 1996-04-10, under 510(k) number K944673.

Who is the listed applicant for MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE?

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

What is the FDA product code for MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE?

The FDA product code for MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE is EZL.

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Other records listing Regulatory & Marketing Services, 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.

K101721WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULAK954752PEDIATRIC EUROPHYLIC FOLEY CATHETERK941342PAIN DOCK941543DIAL MEDICAL KITK944379ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAGK944384ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG

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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

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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