FDA 510(k)

NEO-STAT CO2 <KG

Q: What is the NEO-STAT CO2 <KG?

NEO-STAT CO2 <KG is a medical device that received FDA 510(k) clearance on 2009-02-23. The listed applicant is Mercury Medical. The 510(k) number is K083056.

Q: When did NEO-STAT CO2 <KG receive FDA 510(k) clearance?

NEO-STAT CO2 <KG received FDA 510(k) clearance on 2009-02-23, under 510(k) number K083056.

Q: Who is the listed applicant for NEO-STAT CO2 <KG?

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

Q: What is the FDA product code for NEO-STAT CO2 <KG?

The FDA product code for NEO-STAT CO2 <KG is CCK.

K-Number: K083056 · 2009-02-23

ApplicantMercury Medical

Decision Date2009-02-23

Product CodeCCK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

NEO-STAT CO2 <KG is the device name listed in this FDA 510(k) record. The listed applicant is Mercury Medical. It received FDA 510(k) clearance on 2009-02-23 under 510(k) number K083056. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEO-STAT CO2 <KG?

NEO-STAT CO2 <KG is a medical device that received FDA 510(k) clearance on 2009-02-23. The listed applicant is Mercury Medical. The 510(k) number is K083056.

When did NEO-STAT CO2 <KG receive FDA 510(k) clearance?

NEO-STAT CO2 <KG received FDA 510(k) clearance on 2009-02-23, under 510(k) number K083056.

Who is the listed applicant for NEO-STAT CO2 <KG?

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

What is the FDA product code for NEO-STAT CO2 <KG?

The FDA product code for NEO-STAT CO2 <KG is CCK.

Other records listing Mercury Medical 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.

K090710MERCURY CPAP K032593MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER K031814STATCO2METER, MODEL 10-55372 K031411MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 K021576MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 K001714MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149

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Related Devices (Code: CCK)

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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.