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FDA 510(k)

DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES

K-Number: K013389 · 2002-01-10

ApplicantDatex-Ohmeda
Decision Date2002-01-10
Product CodeOLW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DATEX-OHMEDA S/5 BIS MODULE, M-BIS 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 2002-01-10 under 510(k) number K013389. The device is classified under product code OLW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES?

DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2002-01-10. The listed applicant is Datex-Ohmeda. The 510(k) number is K013389.

When did DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES receive FDA 510(k) clearance?

DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES received FDA 510(k) clearance on 2002-01-10, under 510(k) number K013389.

Who is the listed applicant for DATEX-OHMEDA S/5 BIS MODULE, M-BIS 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 DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES?

The FDA product code for DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES is OLW.

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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: OLW)

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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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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