FDA 510(k)

ULTRASOUND SYSTEMS DRAPE

K-Number: K970885 · 1997-09-22

Decision Date1997-09-22

Product CodeMMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ULTRASOUND SYSTEMS DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Protek Medical Products, Inc.. It received FDA 510(k) clearance on 1997-09-22 under 510(k) number K970885. The device is classified under product code MMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASOUND SYSTEMS DRAPE?

ULTRASOUND SYSTEMS DRAPE is a medical device that received FDA 510(k) clearance on 1997-09-22. The listed applicant is Protek Medical Products, Inc.. The 510(k) number is K970885.

When did ULTRASOUND SYSTEMS DRAPE receive FDA 510(k) clearance?

ULTRASOUND SYSTEMS DRAPE received FDA 510(k) clearance on 1997-09-22, under 510(k) number K970885.

Who is the listed applicant for ULTRASOUND SYSTEMS DRAPE?

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

What is the FDA product code for ULTRASOUND SYSTEMS DRAPE?

The FDA product code for ULTRASOUND SYSTEMS DRAPE is MMP.

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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.

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Other records listing Protek Medical Products, Inc. as applicant

K973958GENERAL PURPOSE ATL NEEDLE GUIDE KIT K973622TRANSDUCER POSITIONER K970893ULTRASOUND TRANSDUCER DRAPE K970889ULTRASOUND TRANSDUCER DRAPE K973362NEEDLE GUIDE/GRID K970891DRAPE, SURGICAL-LATEX

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Related Devices (Code: MMP)

K091178MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREENMtp Medical Technical Promotion GmbH K043234LIGHT DRAPEWrapped IN Comfort K041501GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERSGuangzhou Fortunique , Ltd.K040794INCUBATOR CAPEWrapped IN Comfort K032065MEDLINE BAND BAGS AND EQUIPMENT COVERSMedline Industries, Inc.K023540SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09Valumed

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.