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FDA 510(k)

ALPHA STEREO

K-Number: K934478 · 1995-01-31

ApplicantInstrumentarium Corp.
Decision Date1995-01-31
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ALPHA STEREO is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Corp.. It received FDA 510(k) clearance on 1995-01-31 under 510(k) number K934478. 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 ALPHA STEREO?

ALPHA STEREO is a medical device that received FDA 510(k) clearance on 1995-01-31. The listed applicant is Instrumentarium Corp.. The 510(k) number is K934478.

When did ALPHA STEREO receive FDA 510(k) clearance?

ALPHA STEREO received FDA 510(k) clearance on 1995-01-31, under 510(k) number K934478.

Who is the listed applicant for ALPHA STEREO?

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

What is the FDA product code for ALPHA STEREO?

The FDA product code for ALPHA STEREO is IZH.

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Other records listing Instrumentarium 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.

K022630MODIFICATION TO FOCUSK001729FOCUSK001439ORTHOCEPH OC100 DK992385ORTHOPANTOMOGRAPH OP100DK981641MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQK962638TONOCAP, TC-200 AND ACCESSORY CATHETERS

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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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