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FDA 510(k)

ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE

K-Number: K944381 · 1994-11-30

ApplicantRegulatory & Marketing Services, Inc.
Decision Date1994-11-30
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ORION 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 1994-11-30 under 510(k) number K944381. 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 ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE?

ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE is a medical device that received FDA 510(k) clearance on 1994-11-30. The listed applicant is Regulatory & Marketing Services, Inc.. The 510(k) number is K944381.

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

ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE received FDA 510(k) clearance on 1994-11-30, under 510(k) number K944381.

Who is the listed applicant for ORION 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 ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE?

The FDA product code for ORION 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 CANNULAK944673MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBEK954752PEDIATRIC EUROPHYLIC FOLEY CATHETERK941342PAIN DOCK941543DIAL MEDICAL KITK944379ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND 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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