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FDA 510(k)

PRECISION ONE LIFECARE; DETECTO; DETECTO

K-Number: K130952 · 2013-09-26

ApplicantPrecision One Lifecare, Ltd.
Decision Date2013-09-26
Product CodeMNW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRECISION ONE LIFECARE; DETECTO; DETECTO is the device name listed in this FDA 510(k) record. The listed applicant is Precision One Lifecare, Ltd.. It received FDA 510(k) clearance on 2013-09-26 under 510(k) number K130952. The device is classified under product code MNW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECISION ONE LIFECARE; DETECTO; DETECTO?

PRECISION ONE LIFECARE; DETECTO; DETECTO is a medical device that received FDA 510(k) clearance on 2013-09-26. The listed applicant is Precision One Lifecare, Ltd.. The 510(k) number is K130952.

When did PRECISION ONE LIFECARE; DETECTO; DETECTO receive FDA 510(k) clearance?

PRECISION ONE LIFECARE; DETECTO; DETECTO received FDA 510(k) clearance on 2013-09-26, under 510(k) number K130952.

Who is the listed applicant for PRECISION ONE LIFECARE; DETECTO; DETECTO?

The FDA 510(k) record lists Precision One Lifecare, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRECISION ONE LIFECARE; DETECTO; DETECTO?

The FDA product code for PRECISION ONE LIFECARE; DETECTO; DETECTO is MNW.

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Related Devices (Code: MNW)

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

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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