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FDA 510(k)

CALEO

K-Number: K003067 · 2000-12-13

ApplicantDrager Medizintechnik GmbH
Decision Date2000-12-13
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CALEO is the device name listed in this FDA 510(k) record. The listed applicant is Drager Medizintechnik GmbH. It received FDA 510(k) clearance on 2000-12-13 under 510(k) number K003067. The device is classified under product code FMZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALEO?

CALEO is a medical device that received FDA 510(k) clearance on 2000-12-13. The listed applicant is Drager Medizintechnik GmbH. The 510(k) number is K003067.

When did CALEO receive FDA 510(k) clearance?

CALEO received FDA 510(k) clearance on 2000-12-13, under 510(k) number K003067.

Who is the listed applicant for CALEO?

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

What is the FDA product code for CALEO?

The FDA product code for CALEO is FMZ.

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Other records listing Drager Medizintechnik GmbH 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.

K023289OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072K010793OXYLOG 1000, MODEL 2M86840K012177VENTVIEW, MODEL 8414095K003068SAVINAK010093NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474K010724SOLA 700,SOLA 500, SOLA 300

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Related Devices (Code: FMZ)

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.

K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc.K251619Babyleo TN500Drägerwerk AG & Co. KGaAK251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc.K243437mOm Essential Incubator (ME1)Mom Incubators LimitedK213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc.K190494Infant IncubatorNingbo David Medical Device Co., Ltd.

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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