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FDA 510(k)

OMNIVAC (VACUUM ELECTRODE SYSTEM)

K-Number: K861039 · 1986-09-26

ApplicantPhysio Technology, Inc.
Decision Date1986-09-26
Product CodeLIH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OMNIVAC (VACUUM ELECTRODE SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Physio Technology, Inc.. It received FDA 510(k) clearance on 1986-09-26 under 510(k) number K861039. The device is classified under product code LIH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIVAC (VACUUM ELECTRODE SYSTEM)?

OMNIVAC (VACUUM ELECTRODE SYSTEM) is a medical device that received FDA 510(k) clearance on 1986-09-26. The listed applicant is Physio Technology, Inc.. The 510(k) number is K861039.

When did OMNIVAC (VACUUM ELECTRODE SYSTEM) receive FDA 510(k) clearance?

OMNIVAC (VACUUM ELECTRODE SYSTEM) received FDA 510(k) clearance on 1986-09-26, under 510(k) number K861039.

Who is the listed applicant for OMNIVAC (VACUUM ELECTRODE SYSTEM)?

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

What is the FDA product code for OMNIVAC (VACUUM ELECTRODE SYSTEM)?

The FDA product code for OMNIVAC (VACUUM ELECTRODE SYSTEM) is LIH.

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Other records listing Physio Technology, 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.

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Related Devices (Code: LIH)

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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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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