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FDA 510(k)

DINAMAP ADULT/PED./NEONATAL VITAL SIGNS

K-Number: K813527 · 1982-01-12

ApplicantCritikon Company, LLC
Decision Date1982-01-12
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DINAMAP ADULT/PED./NEONATAL VITAL SIGNS is the device name listed in this FDA 510(k) record. The listed applicant is Critikon Company, LLC. It received FDA 510(k) clearance on 1982-01-12 under 510(k) number K813527. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DINAMAP ADULT/PED./NEONATAL VITAL SIGNS?

DINAMAP ADULT/PED./NEONATAL VITAL SIGNS is a medical device that received FDA 510(k) clearance on 1982-01-12. The listed applicant is Critikon Company, LLC. The 510(k) number is K813527.

When did DINAMAP ADULT/PED./NEONATAL VITAL SIGNS receive FDA 510(k) clearance?

DINAMAP ADULT/PED./NEONATAL VITAL SIGNS received FDA 510(k) clearance on 1982-01-12, under 510(k) number K813527.

Who is the listed applicant for DINAMAP ADULT/PED./NEONATAL VITAL SIGNS?

The FDA 510(k) record lists Critikon Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DINAMAP ADULT/PED./NEONATAL VITAL SIGNS?

The FDA product code for DINAMAP ADULT/PED./NEONATAL VITAL SIGNS is DXN.

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Other records listing Critikon Company, LLC 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.

K002248DINAMAP PRO 1000 MONITOR, MODEL 1000K000500DINAMAP ADVANCED NIBP MODULEK992638DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400K982342DINAMAP MPS SELECT PORTABLE MONITORK943709DINAMAP PLUS VITAL SIGNS MONOITORK942700DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340

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Related Devices (Code: DXN)

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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