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FDA 510(k)

MEDISYSTEM NEGATIVE PRESSURE

K-Number: K811839 · 1981-09-08

Decision Date1981-09-08
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDISYSTEM NEGATIVE PRESSURE is the device name listed in this FDA 510(k) record. The listed applicant is Medisystems Corp.. It received FDA 510(k) clearance on 1981-09-08 under 510(k) number K811839. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDISYSTEM NEGATIVE PRESSURE?

MEDISYSTEM NEGATIVE PRESSURE is a medical device that received FDA 510(k) clearance on 1981-09-08. The listed applicant is Medisystems Corp.. The 510(k) number is K811839.

When did MEDISYSTEM NEGATIVE PRESSURE receive FDA 510(k) clearance?

MEDISYSTEM NEGATIVE PRESSURE received FDA 510(k) clearance on 1981-09-08, under 510(k) number K811839.

Who is the listed applicant for MEDISYSTEM NEGATIVE PRESSURE?

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

What is the FDA product code for MEDISYSTEM NEGATIVE PRESSURE?

The FDA product code for MEDISYSTEM NEGATIVE PRESSURE is FJK.

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 Medisystems Corp. 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 22 devices →

Related Devices (Code: FJK)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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