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FDA 510(k)

MOBILE CAREGUIDE 2100 OXIMETER

K-Number: K122645 · 2012-12-05

ApplicantReflectance Medical, Inc.
Decision Date2012-12-05
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MOBILE CAREGUIDE 2100 OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Reflectance Medical, Inc.. It received FDA 510(k) clearance on 2012-12-05 under 510(k) number K122645. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOBILE CAREGUIDE 2100 OXIMETER?

MOBILE CAREGUIDE 2100 OXIMETER is a medical device that received FDA 510(k) clearance on 2012-12-05. The listed applicant is Reflectance Medical, Inc.. The 510(k) number is K122645.

When did MOBILE CAREGUIDE 2100 OXIMETER receive FDA 510(k) clearance?

MOBILE CAREGUIDE 2100 OXIMETER received FDA 510(k) clearance on 2012-12-05, under 510(k) number K122645.

Who is the listed applicant for MOBILE CAREGUIDE 2100 OXIMETER?

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

What is the FDA product code for MOBILE CAREGUIDE 2100 OXIMETER?

The FDA product code for MOBILE CAREGUIDE 2100 OXIMETER is MUD.

Related Clinical Trials

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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Other records listing Reflectance Medical, Inc. 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.

K130079MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETERK113656CAREGUIDE OXIMETER

Related Devices (Code: MUD)

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.

K254129Spectrum-2Neko Health ABK243324Masimo O3 Regional OximeterMasimo CorporationK250519Lap.Ox™ Laparoscopic Tissue OximeterViOptix, Inc.K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards LifesciencesK241393ODI-TechOdi Medical ASK240601SnapshotNIR model KD205Kent Imaging, Inc.

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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