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FDA 510(k)

MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES

K-Number: K012837 · 2001-09-14

ApplicantDatex-Ohmeda
Decision Date2001-09-14
Product CodeMLD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Datex-Ohmeda. It received FDA 510(k) clearance on 2001-09-14 under 510(k) number K012837. The device is classified under product code MLD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES?

MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2001-09-14. The listed applicant is Datex-Ohmeda. The 510(k) number is K012837.

When did MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES receive FDA 510(k) clearance?

MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES received FDA 510(k) clearance on 2001-09-14, under 510(k) number K012837.

Who is the listed applicant for MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES?

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

What is the FDA product code for MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES?

The FDA product code for MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES is MLD.

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Other records listing Datex-Ohmeda 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.

K231964Novii+ Wireless Patch SystemK131945GE DATEX-OHMEDA AVANCE CS2K122445AESPIRE 7900, AESPIRE VIEWK111116ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000K071142GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEMK042891DATEX-OHMEDA OXY-AFR SENSOR

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Related Devices (Code: MLD)

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.

K101602VITAL SIGNS MONITORCriticare Systems, Inc.K080461STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0Philips Medical SystemsK022740DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWAREDatex-OhmedaK002105SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSISSiemens Medical Solutions USA, Inc.K992323DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIESDatex-Ohmeda, Inc.K982104ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500Medical Data Electronics

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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