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FDA 510(k)

ULTRASOUND PROBE DRAPE

K-Number: K940151 · 1994-11-14

ApplicantHydro-Med Products, Inc.
Decision Date1994-11-14
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND PROBE DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Hydro-Med Products, Inc.. It received FDA 510(k) clearance on 1994-11-14 under 510(k) number K940151. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASOUND PROBE DRAPE?

ULTRASOUND PROBE DRAPE is a medical device that received FDA 510(k) clearance on 1994-11-14. The listed applicant is Hydro-Med Products, Inc.. The 510(k) number is K940151.

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

ULTRASOUND PROBE DRAPE received FDA 510(k) clearance on 1994-11-14, under 510(k) number K940151.

Who is the listed applicant for ULTRASOUND PROBE DRAPE?

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

What is the FDA product code for ULTRASOUND PROBE DRAPE?

The FDA product code for ULTRASOUND PROBE DRAPE is IYO.

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Other records listing Hydro-Med 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.

K944198SURGICAL MICROSCOPE DRAPEK934630UNIVERSAL VIDEO/LASER ARM DRAPEK940152CAMERA COVER WITH TEAR TIPK923099X-RAY DRAPESK863872TAMPER HAMPERK853281EASYTOP

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Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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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