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FDA 510(k)

COBEAU

K-Number: K812548 · 1981-09-25

ApplicantSci-Pharm, Inc.
Decision Date1981-09-25
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COBEAU is the device name listed in this FDA 510(k) record. The listed applicant is Sci-Pharm, Inc.. It received FDA 510(k) clearance on 1981-09-25 under 510(k) number K812548. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBEAU?

COBEAU is a medical device that received FDA 510(k) clearance on 1981-09-25. The listed applicant is Sci-Pharm, Inc.. The 510(k) number is K812548.

When did COBEAU receive FDA 510(k) clearance?

COBEAU received FDA 510(k) clearance on 1981-09-25, under 510(k) number K812548.

Who is the listed applicant for COBEAU?

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

What is the FDA product code for COBEAU?

The FDA product code for COBEAU is LBH.

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Other records listing Sci-Pharm, 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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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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