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FDA 510(k)

INTERSPEC APOGEE

K-Number: K890173 · 1989-04-14

ApplicantInterspec, Inc.
Decision Date1989-04-14
Product CodeIYO
Advisory CommitteeRA
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 1989-04-14 under 510(k) number K890173. 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 INTERSPEC APOGEE?

INTERSPEC APOGEE is a medical device that received FDA 510(k) clearance on 1989-04-14. The listed applicant is Interspec, Inc.. The 510(k) number is K890173.

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

INTERSPEC APOGEE received FDA 510(k) clearance on 1989-04-14, under 510(k) number K890173.

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 IYO.

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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: IYO)

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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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