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FDA 510(k)

ULTRASOUND TRANSDUCER DRAPE

K-Number: K970893 · 1997-10-20

ApplicantProtek Medical Products, Inc.
Decision Date1997-10-20
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND TRANSDUCER 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 1997-10-20 under 510(k) number K970893. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASOUND TRANSDUCER DRAPE?

ULTRASOUND TRANSDUCER DRAPE is a medical device that received FDA 510(k) clearance on 1997-10-20. The listed applicant is Protek Medical Products, Inc.. The 510(k) number is K970893.

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

ULTRASOUND TRANSDUCER DRAPE received FDA 510(k) clearance on 1997-10-20, under 510(k) number K970893.

Who is the listed applicant for ULTRASOUND TRANSDUCER 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 TRANSDUCER DRAPE?

The FDA product code for ULTRASOUND TRANSDUCER DRAPE is FYA.

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Other records listing Protek Medical Products, 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.

K973958GENERAL PURPOSE ATL NEEDLE GUIDE KITK973622TRANSDUCER POSITIONERK970889ULTRASOUND TRANSDUCER DRAPEK973362NEEDLE GUIDE/GRIDK970885ULTRASOUND SYSTEMS DRAPEK970891DRAPE, SURGICAL-LATEX

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Related Devices (Code: FYA)

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.

K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation GownsPrinciple & Will Co., Ltd.K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery StudioK252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, LLC

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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