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FDA 510(k)

INTERSPEC APOGEE, MODIFICATION

K-Number: K910049 · 1991-04-29

ApplicantInterspec, Inc.
Decision Date1991-04-29
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTERSPEC APOGEE, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Interspec, Inc.. It received FDA 510(k) clearance on 1991-04-29 under 510(k) number K910049. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERSPEC APOGEE, MODIFICATION?

INTERSPEC APOGEE, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-04-29. The listed applicant is Interspec, Inc.. The 510(k) number is K910049.

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

INTERSPEC APOGEE, MODIFICATION received FDA 510(k) clearance on 1991-04-29, under 510(k) number K910049.

Who is the listed applicant for INTERSPEC APOGEE, MODIFICATION?

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, MODIFICATION?

The FDA product code for INTERSPEC APOGEE, MODIFICATION is DPW.

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 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 KITK903839INTERSPEC APOGEE

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Related Devices (Code: DPW)

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.

K260700BlueDop Vascular ExpertBlueDop Medical, Ltd.K252810FloPatch FP120Flosonics MedicalK251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)Remington Medical, Inc.K251114FloPatch FP120Flosonics MedicalK243852Elfor-LElfi-Tech , Ltd.K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)Remington Medical, 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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