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FDA 510(k)

CRITIKON #817 ESOPHAGEAL MULTI-PROBE

K-Number: K821890 · 1982-08-03

ApplicantCritikon Company, LLC
Decision Date1982-08-03
Product CodeBZT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CRITIKON #817 ESOPHAGEAL MULTI-PROBE 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 1982-08-03 under 510(k) number K821890. The device is classified under product code BZT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRITIKON #817 ESOPHAGEAL MULTI-PROBE?

CRITIKON #817 ESOPHAGEAL MULTI-PROBE is a medical device that received FDA 510(k) clearance on 1982-08-03. The listed applicant is Critikon Company, LLC. The 510(k) number is K821890.

When did CRITIKON #817 ESOPHAGEAL MULTI-PROBE receive FDA 510(k) clearance?

CRITIKON #817 ESOPHAGEAL MULTI-PROBE received FDA 510(k) clearance on 1982-08-03, under 510(k) number K821890.

Who is the listed applicant for CRITIKON #817 ESOPHAGEAL MULTI-PROBE?

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 CRITIKON #817 ESOPHAGEAL MULTI-PROBE?

The FDA product code for CRITIKON #817 ESOPHAGEAL MULTI-PROBE is BZT.

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Other records listing Critikon Company, LLC as applicant

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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: BZT)

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.

K251025Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)Covidien, LLCK193027Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 FrenchDeroyal Industries, Inc.K111050ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FRStarboard Medical, LLCK092716ESOPHAGEAL STETHOSCOPETruer Medical, Inc.K072621ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSORCincinnati Sub-Zero Products, Inc.K062020LIFESOUND ESOPHAGEAL STETHOSCOPENovamed, LLC

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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