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FDA 510(k)

PNEUMOCLEAR

K-Number: K201361 · 2020-07-29

Decision Date2020-07-29
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PNEUMOCLEAR is the device name listed in this FDA 510(k) record. The listed applicant is W.O.M. World of Medicine GmbH. It received FDA 510(k) clearance on 2020-07-29 under 510(k) number K201361. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PNEUMOCLEAR?

PNEUMOCLEAR is a medical device that received FDA 510(k) clearance on 2020-07-29. The listed applicant is W.O.M. World of Medicine GmbH. The 510(k) number is K201361.

When did PNEUMOCLEAR receive FDA 510(k) clearance?

PNEUMOCLEAR received FDA 510(k) clearance on 2020-07-29, under 510(k) number K201361.

Who is the listed applicant for PNEUMOCLEAR?

The FDA 510(k) record lists W.O.M. World of Medicine GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PNEUMOCLEAR?

The FDA product code for PNEUMOCLEAR is HIF.

Other records listing W.O.M. World of Medicine GmbH 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 8 devices →

Related Devices (Code: HIF)

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.