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FDA 510(k)

SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA

K-Number: K912145 · 1992-05-05

ApplicantS & W Medico Teknik
Decision Date1992-05-05
Product CodeCCE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA is the device name listed in this FDA 510(k) record. The listed applicant is S & W Medico Teknik. It received FDA 510(k) clearance on 1992-05-05 under 510(k) number K912145. The device is classified under product code CCE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA?

SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA is a medical device that received FDA 510(k) clearance on 1992-05-05. The listed applicant is S & W Medico Teknik. The 510(k) number is K912145.

When did SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA receive FDA 510(k) clearance?

SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA received FDA 510(k) clearance on 1992-05-05, under 510(k) number K912145.

Who is the listed applicant for SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA?

The FDA 510(k) record lists S & W Medico Teknik as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA?

The FDA product code for SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA is CCE.

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Other records listing S & W Medico Teknik 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.

K9409339267 SPO2 ATHENA MODULEK913013TCPO2 9260 MODULE - SYSTEM ATHENAK915633MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENAK9301349055 IRCA OPTION FOR SYSTEM ATHENA 9050 NTK9234189293/1 INTERFACE MODULEK911611SYSTEM ATHENA, MODIFICATION

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Related Devices (Code: CCE)

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.

K935778VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEMVia Medical Corp.K910453TOPS NEEDLE TIP PROBE & PVC TIP PROBEBaxter Healthcare CorpK905397PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEMPuritan Bennett Corp.K896311OPTEX BLOOD GAS MONITORING SYSTEMOptex BiomedicalK890624TISSUE OXYGEN MONITOR SYSTEM, MODEL IIBaxter Healthcare CorpK895150CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORINGShiley, Inc.

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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