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FDA 510(k)

OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100

K-Number: K853786 · 1985-10-16

ApplicantAmerican Bentley
Decision Date1985-10-16
Product CodeCCE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100 is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1985-10-16 under 510(k) number K853786. 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 OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100?

OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100 is a medical device that received FDA 510(k) clearance on 1985-10-16. The listed applicant is American Bentley. The 510(k) number is K853786.

When did OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100 receive FDA 510(k) clearance?

OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100 received FDA 510(k) clearance on 1985-10-16, under 510(k) number K853786.

Who is the listed applicant for OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100?

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

What is the FDA product code for OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100?

The FDA product code for OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100 is CCE.

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Other records listing American Bentley 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.

K872896UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100K873923INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTERK870804CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100K872167CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500K872133OXYGENATOR MODEL NO. BENTLEY 5 PLUSK870911INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY

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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.K912145SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIAS & W Medico TeknikK910453TOPS 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 Corp

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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