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FDA 510(k)

ECOGEL 200 ULTRASOUND GEL

K-Number: K955246 · 1996-02-21

ApplicantEco-Med Pharmaceuticals, Inc.
Decision Date1996-02-21
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECOGEL 200 ULTRASOUND GEL is the device name listed in this FDA 510(k) record. The listed applicant is Eco-Med Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1996-02-21 under 510(k) number K955246. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECOGEL 200 ULTRASOUND GEL?

ECOGEL 200 ULTRASOUND GEL is a medical device that received FDA 510(k) clearance on 1996-02-21. The listed applicant is Eco-Med Pharmaceuticals, Inc.. The 510(k) number is K955246.

When did ECOGEL 200 ULTRASOUND GEL receive FDA 510(k) clearance?

ECOGEL 200 ULTRASOUND GEL received FDA 510(k) clearance on 1996-02-21, under 510(k) number K955246.

Who is the listed applicant for ECOGEL 200 ULTRASOUND GEL?

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

What is the FDA product code for ECOGEL 200 ULTRASOUND GEL?

The FDA product code for ECOGEL 200 ULTRASOUND GEL is ITX.

Related Clinical Trials

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Other records listing Eco-Med Pharmaceuticals, 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.

K962840ECOLOTION TRANSMISSION AND MASSAGE LOTIONK962681ECOGEL 300 TENS GELK961757ECOGEL 100 ULTRASOUND GEL

Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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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