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FDA 510(k)

DIGITEC TWO STAGE COMPRESSION KIT

K-Number: K993681 · 1999-12-21

ApplicantDigitec Medical Service Corp.
Decision Date1999-12-21
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITEC TWO STAGE COMPRESSION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Digitec Medical Service Corp.. It received FDA 510(k) clearance on 1999-12-21 under 510(k) number K993681. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITEC TWO STAGE COMPRESSION KIT?

DIGITEC TWO STAGE COMPRESSION KIT is a medical device that received FDA 510(k) clearance on 1999-12-21. The listed applicant is Digitec Medical Service Corp.. The 510(k) number is K993681.

When did DIGITEC TWO STAGE COMPRESSION KIT receive FDA 510(k) clearance?

DIGITEC TWO STAGE COMPRESSION KIT received FDA 510(k) clearance on 1999-12-21, under 510(k) number K993681.

Who is the listed applicant for DIGITEC TWO STAGE COMPRESSION KIT?

The FDA 510(k) record lists Digitec Medical Service Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITEC TWO STAGE COMPRESSION KIT?

The FDA product code for DIGITEC TWO STAGE COMPRESSION KIT is IZH.

Related Clinical Trials

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 Digitec Medical Service Corp. 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.

K010792MAMMOGRAPH

Related Devices (Code: IZH)

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.

K203509SMART FINDERIms Giotto S.P.A.K202294Affirm Contrast BiopsyHologic, Inc.K191495Biopsy PositionerFujifilm CorporationK161575Affirm Lateral Arm Upright Biopsy AccessoryHologicK161920Comfort CoverPrecision Dynamics CorporationK153486Affirm Prone Biopsy SystemHologic, 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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