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FDA 510(k)

TAMA BEMS device

K-Number: K173093 · 2018-06-05

Decision Date2018-06-05
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TAMA BEMS device is the device name listed in this FDA 510(k) record. The listed applicant is Tama Research Corporation. It received FDA 510(k) clearance on 2018-06-05 under 510(k) number K173093. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TAMA BEMS device?

TAMA BEMS device is a medical device that received FDA 510(k) clearance on 2018-06-05. The listed applicant is Tama Research Corporation. The 510(k) number is K173093.

When did TAMA BEMS device receive FDA 510(k) clearance?

TAMA BEMS device received FDA 510(k) clearance on 2018-06-05, under 510(k) number K173093.

Who is the listed applicant for TAMA BEMS device?

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

What is the FDA product code for TAMA BEMS device?

The FDA product code for TAMA BEMS device is NFO.

Related Devices (Code: NFO)

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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