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FDA 510(k)

CMR 300, ROWATER TREATMENT UNIT

K-Number: K802474 · 1980-12-15

ApplicantU-Marc, Inc.
Decision Date1980-12-15
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CMR 300, ROWATER TREATMENT UNIT is the device name listed in this FDA 510(k) record. The listed applicant is U-Marc, Inc.. It received FDA 510(k) clearance on 1980-12-15 under 510(k) number K802474. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CMR 300, ROWATER TREATMENT UNIT?

CMR 300, ROWATER TREATMENT UNIT is a medical device that received FDA 510(k) clearance on 1980-12-15. The listed applicant is U-Marc, Inc.. The 510(k) number is K802474.

When did CMR 300, ROWATER TREATMENT UNIT receive FDA 510(k) clearance?

CMR 300, ROWATER TREATMENT UNIT received FDA 510(k) clearance on 1980-12-15, under 510(k) number K802474.

Who is the listed applicant for CMR 300, ROWATER TREATMENT UNIT?

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

What is the FDA product code for CMR 300, ROWATER TREATMENT UNIT?

The FDA product code for CMR 300, ROWATER TREATMENT UNIT is FIP.

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Related Devices (Code: FIP)

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

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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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