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FDA 510(k)

SMART-WELL INCUBATOR

K-Number: K122362 · 2013-03-26

ApplicantMesa Laboratories, Inc.
Decision Date2013-03-26
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SMART-WELL INCUBATOR is the device name listed in this FDA 510(k) record. The listed applicant is Mesa Laboratories, Inc.. It received FDA 510(k) clearance on 2013-03-26 under 510(k) number K122362. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMART-WELL INCUBATOR?

SMART-WELL INCUBATOR is a medical device that received FDA 510(k) clearance on 2013-03-26. The listed applicant is Mesa Laboratories, Inc.. The 510(k) number is K122362.

When did SMART-WELL INCUBATOR receive FDA 510(k) clearance?

SMART-WELL INCUBATOR received FDA 510(k) clearance on 2013-03-26, under 510(k) number K122362.

Who is the listed applicant for SMART-WELL INCUBATOR?

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

What is the FDA product code for SMART-WELL INCUBATOR?

The FDA product code for SMART-WELL INCUBATOR is FRC.

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Other records listing Mesa Laboratories, Inc. as applicant

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Related Devices (Code: FRC)

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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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