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FDA 510(k)

INTERSPEC APOGEE

K-Number: K903839 · 1990-11-16

ApplicantInterspec, Inc.
Decision Date1990-11-16
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTERSPEC APOGEE is the device name listed in this FDA 510(k) record. The listed applicant is Interspec, Inc.. It received FDA 510(k) clearance on 1990-11-16 under 510(k) number K903839. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERSPEC APOGEE?

INTERSPEC APOGEE is a medical device that received FDA 510(k) clearance on 1990-11-16. The listed applicant is Interspec, Inc.. The 510(k) number is K903839.

When did INTERSPEC APOGEE receive FDA 510(k) clearance?

INTERSPEC APOGEE received FDA 510(k) clearance on 1990-11-16, under 510(k) number K903839.

Who is the listed applicant for INTERSPEC APOGEE?

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

What is the FDA product code for INTERSPEC APOGEE?

The FDA product code for INTERSPEC APOGEE is DXK.

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Other records listing Interspec, 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.

K940671INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETERK924231INTERSPEC APOGEE CLAK915696INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDEK920678ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETERK911073PROBE REFILL KITK910049INTERSPEC APOGEE, MODIFICATION

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Related Devices (Code: DXK)

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.

K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific CorporationK160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific CorporationK031148IN-VISION IMAGING SYSTEMJomed, Inc.K9348879750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/SK913209ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.

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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