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FDA 510(k)

DINAMAP MODEL 850

K-Number: K780127 · 1978-01-31

ApplicantApplied Medical Research
Decision Date1978-01-31
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DINAMAP MODEL 850 is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Research. It received FDA 510(k) clearance on 1978-01-31 under 510(k) number K780127. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DINAMAP MODEL 850?

DINAMAP MODEL 850 is a medical device that received FDA 510(k) clearance on 1978-01-31. The listed applicant is Applied Medical Research. The 510(k) number is K780127.

When did DINAMAP MODEL 850 receive FDA 510(k) clearance?

DINAMAP MODEL 850 received FDA 510(k) clearance on 1978-01-31, under 510(k) number K780127.

Who is the listed applicant for DINAMAP MODEL 850?

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

What is the FDA product code for DINAMAP MODEL 850?

The FDA product code for DINAMAP MODEL 850 is DRS.

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Other records listing Applied Medical Research 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.

K800025DINAMAP RESEARCH MONITOR 1245K791580CEREBRAL FUNCTION MONITOR 870K791159DINAMAP MODEL 855K790322OPTIONAL ACCESSORY FOOT SWITCH MODEL 100K790328MODEL 1051, MONITORK782073DINAMAP MODELS 1160 AND 1165

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Related Devices (Code: DRS)

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.

K254074TruPressProcerus EnterprisesK242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLCK221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte. , Ltd.K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K161408Compass Cast and MAPCenturion Medical Products Corporation

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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