FDA 510(k)

TRANSDUCER POSITIONER

K-Number: K973622 · 1997-11-26

Decision Date1997-11-26

Product CodeITX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TRANSDUCER POSITIONER 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 1997-11-26 under 510(k) number K973622. 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 TRANSDUCER POSITIONER?

TRANSDUCER POSITIONER is a medical device that received FDA 510(k) clearance on 1997-11-26. The listed applicant is Protek Medical Products, Inc.. The 510(k) number is K973622.

When did TRANSDUCER POSITIONER receive FDA 510(k) clearance?

TRANSDUCER POSITIONER received FDA 510(k) clearance on 1997-11-26, under 510(k) number K973622.

Who is the listed applicant for TRANSDUCER POSITIONER?

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 TRANSDUCER POSITIONER?

The FDA product code for TRANSDUCER POSITIONER is ITX.

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Other records listing Protek Medical Products, Inc. as applicant

K973958GENERAL PURPOSE ATL NEEDLE GUIDE KIT K970893ULTRASOUND TRANSDUCER DRAPE K970889ULTRASOUND TRANSDUCER DRAPE K973362NEEDLE GUIDE/GRID K970885ULTRASOUND SYSTEMS DRAPE K970891DRAPE, SURGICAL-LATEX

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Related Devices (Code: ITX)

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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.