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FDA 510(k)

DISPOSABLE COLLECTION BOTTLE W/TUBING

K-Number: K822311 · 1982-08-20

Decision Date1982-08-20
Product CodeGCX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE COLLECTION BOTTLE W/TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Ohio Medical Products. It received FDA 510(k) clearance on 1982-08-20 under 510(k) number K822311. The device is classified under product code GCX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE COLLECTION BOTTLE W/TUBING?

DISPOSABLE COLLECTION BOTTLE W/TUBING is a medical device that received FDA 510(k) clearance on 1982-08-20. The listed applicant is Ohio Medical Products. The 510(k) number is K822311.

When did DISPOSABLE COLLECTION BOTTLE W/TUBING receive FDA 510(k) clearance?

DISPOSABLE COLLECTION BOTTLE W/TUBING received FDA 510(k) clearance on 1982-08-20, under 510(k) number K822311.

Who is the listed applicant for DISPOSABLE COLLECTION BOTTLE W/TUBING?

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

What is the FDA product code for DISPOSABLE COLLECTION BOTTLE W/TUBING?

The FDA product code for DISPOSABLE COLLECTION BOTTLE W/TUBING is GCX.

Related Clinical Trials

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.

Other records listing Ohio Medical 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.

View all 47 devices →

Related Devices (Code: GCX)

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.

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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