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FDA 510(k)

BIOBRANE R II BRAND

K-Number: K820620 · 1982-08-03

ApplicantWoodroof Mfg., Inc.
Decision Date1982-08-03
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

BIOBRANE R II BRAND is the device name listed in this FDA 510(k) record. The listed applicant is Woodroof Mfg., Inc.. It received FDA 510(k) clearance on 1982-08-03 under 510(k) number K820620. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOBRANE R II BRAND?

BIOBRANE R II BRAND is a medical device that received FDA 510(k) clearance on 1982-08-03. The listed applicant is Woodroof Mfg., Inc.. The 510(k) number is K820620.

When did BIOBRANE R II BRAND receive FDA 510(k) clearance?

BIOBRANE R II BRAND received FDA 510(k) clearance on 1982-08-03, under 510(k) number K820620.

Who is the listed applicant for BIOBRANE R II BRAND?

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

What is the FDA product code for BIOBRANE R II BRAND?

The FDA product code for BIOBRANE R II BRAND is FRO. This falls under the Anesthesiology category.

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Related Devices (Code: FRO)

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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