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FDA 510(k)

ORTHO-LEVEL

K-Number: K822305 · 1982-08-20

ApplicantFrontier Products
Decision Date1982-08-20
Product CodeHTH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHO-LEVEL is the device name listed in this FDA 510(k) record. The listed applicant is Frontier Products. It received FDA 510(k) clearance on 1982-08-20 under 510(k) number K822305. The device is classified under product code HTH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO-LEVEL?

ORTHO-LEVEL is a medical device that received FDA 510(k) clearance on 1982-08-20. The listed applicant is Frontier Products. The 510(k) number is K822305.

When did ORTHO-LEVEL receive FDA 510(k) clearance?

ORTHO-LEVEL received FDA 510(k) clearance on 1982-08-20, under 510(k) number K822305.

Who is the listed applicant for ORTHO-LEVEL?

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

What is the FDA product code for ORTHO-LEVEL?

The FDA product code for ORTHO-LEVEL is HTH.

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Other records listing Frontier Products 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.

K831001UNICUFF-BLOOD PRESSURE CUFFK812639UNICUFFK801099UNICUF, BLOOD PRESSURE CUFF

Related Devices (Code: HTH)

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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