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FDA 510(k)

OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000)

K-Number: K951806 · 1995-07-06

ApplicantOpgal Optronic Industries
Decision Date1995-07-06
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000) is the device name listed in this FDA 510(k) record. The listed applicant is Opgal Optronic Industries. It received FDA 510(k) clearance on 1995-07-06 under 510(k) number K951806. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000)?

OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000) is a medical device that received FDA 510(k) clearance on 1995-07-06. The listed applicant is Opgal Optronic Industries. The 510(k) number is K951806.

When did OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000) receive FDA 510(k) clearance?

OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000) received FDA 510(k) clearance on 1995-07-06, under 510(k) number K951806.

Who is the listed applicant for OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000)?

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

What is the FDA product code for OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000)?

The FDA product code for OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000) is LHQ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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