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FDA 510(k)

OSCAR(TM) II CAPNOMETER & PULSE OXIMETER

K-Number: K904843 · 1991-04-09

ApplicantDalton Instrument Corp.
Decision Date1991-04-09
Product CodeCBR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OSCAR(TM) II CAPNOMETER & PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Dalton Instrument Corp.. It received FDA 510(k) clearance on 1991-04-09 under 510(k) number K904843. The device is classified under product code CBR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSCAR(TM) II CAPNOMETER & PULSE OXIMETER?

OSCAR(TM) II CAPNOMETER & PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 1991-04-09. The listed applicant is Dalton Instrument Corp.. The 510(k) number is K904843.

When did OSCAR(TM) II CAPNOMETER & PULSE OXIMETER receive FDA 510(k) clearance?

OSCAR(TM) II CAPNOMETER & PULSE OXIMETER received FDA 510(k) clearance on 1991-04-09, under 510(k) number K904843.

Who is the listed applicant for OSCAR(TM) II CAPNOMETER & PULSE OXIMETER?

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

What is the FDA product code for OSCAR(TM) II CAPNOMETER & PULSE OXIMETER?

The FDA product code for OSCAR(TM) II CAPNOMETER & PULSE OXIMETER is CBR.

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Other records listing Dalton Instrument Corp. 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.

K101611RELAY POWER WHEELCHAIRK101719TACAMO MANUAL WHEELCHAIRK850178DALTON FOLDING WHEELCHAIRS

Related Devices (Code: CBR)

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.

K112173SPEACELABS MULTIGAS MODULESpacelabs HealthcareK053599SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIESSpacelabs Medical, Inc.K954962SPACELABS MEDICAL MULTIGAS ANALYZERSpacelabs, Inc.K853360N20 TESTErich Jaeger, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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