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FDA 510(k)

BLOOD FLOW ANALYZER

K-Number: K970887 · 1997-06-17

ApplicantParadigm Medical Industries, Inc.
Decision Date1997-06-17
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BLOOD FLOW ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Paradigm Medical Industries, Inc.. It received FDA 510(k) clearance on 1997-06-17 under 510(k) number K970887. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD FLOW ANALYZER?

BLOOD FLOW ANALYZER is a medical device that received FDA 510(k) clearance on 1997-06-17. The listed applicant is Paradigm Medical Industries, Inc.. The 510(k) number is K970887.

When did BLOOD FLOW ANALYZER receive FDA 510(k) clearance?

BLOOD FLOW ANALYZER received FDA 510(k) clearance on 1997-06-17, under 510(k) number K970887.

Who is the listed applicant for BLOOD FLOW ANALYZER?

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

What is the FDA product code for BLOOD FLOW ANALYZER?

The FDA product code for BLOOD FLOW ANALYZER is HKY.

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Other records listing Paradigm Medical Industries, 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.

K050980ULTRASONIC BIO-MICROSCOPE, MODEL P60K023245BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01K003318PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-XK003141UBM PLUS, MODEL P45K002228PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-XK981109QUITETIP

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Related Devices (Code: HKY)

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.

K241447iCare ST500 (TA04)Icare Finland OYK233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)Reichert, Inc.K234037CATS-L Tonometer™ PrismCats Tonometer, LLCK232143Applanation Tonometer HT-5000Huvitz Co., Ltd.K220852iCare IC200Icare Finland OYK211355iCare HOME2Icare Finland OY

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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